Company · US
Stryker Spine
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
75510(k) clearances (2 in 12 months)
99recalls (0 in 12 months)
56recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 44 |
| NKB | Thoracolumbosacral Pedicle Screw System | 27 |
| LXH | Orthopedic Manual Surgical Instrument | 21 |
| MDM | Instrument, Manual, Surgical, General Use | 14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 9 |
| MNI | Orthosis, Spinal Pedicle Fixation | 9 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 8 |
| MQP | Spinal Vertebral Body Replacement Device | 8 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 6 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 |
| MQV | Filler, Bone Void, Calcium Compound | 2 |
| NDN | Cement, Bone, Vertebroplasty | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 |
| FST | Light, Surgical, Fiberoptic | 1 |
| GAD | Retractor | 1 |
| GXZ | Electrode, Needle | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HXX | Screwdriver | 1 |
| LHX | Trousers, Anti-Shock | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2026 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical C Stryker Spine | ODP |
| Apr 24, 2026 | K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTr Stryker Spine | MQV |
| Nov 7, 2024 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small S Stryker Spine | KWQ |
| Aug 29, 2024 | K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTr Stryker Spine | MQV |
| Jun 8, 2023 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conv Stryker Spine | NKB |
| Feb 14, 2023 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expanda Stryker Spine | ODP |
| Mar 23, 2021 | K203205 | Navigated Spine Instruments Stryker Spine | OLO |
| Apr 23, 2020 | K200666 | Stryker Xia 3 Power Adaptor Stryker Spine | NKB |
| Jul 25, 2019 | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage Stryker Spine | MAX |
| Jan 10, 2019 | K183071 | VLIFT-s Vertebral Body Replacement System Stryker Spine | PLR |
| Jul 18, 2018 | K181014 | Tritanium PL Cage Stryker Spine | MAX |
| Sep 6, 2017 | K171496 | Tritanium C Anterior Cervical Cage Stryker Spine | ODP |
| Jul 15, 2016 | K161407 | Ascential IBD PEEKc Spacer Stryker Spine | ODP |
| Dec 18, 2015 | K152532 | AERO -C Cervical Cage System Stryker Spine | ODP |
| Dec 17, 2013 | K133188 | MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL Stryker Spine | NKB |
| Nov 18, 2013 | K132968 | UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) Stryker Spine | PEK |
| Dec 7, 2012 | K122845 | ES2 SPINAL SYSTEM MODEL 48280XXXX Stryker Spine | NKB |
| Nov 1, 2012 | K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 Stryker Spine | FST |
| Oct 25, 2012 | K120869 | ANCHOR-L LUMBAR CAGE Stryker Spine | OVD |
| Aug 28, 2012 | K113666 | XIA 3 SPINAL SYSTEM Stryker Spine | NKB |
| Aug 20, 2012 | K120486 | AVS AS PEEK SPACER Stryker Spine | ODP |
| Apr 16, 2012 | K113802 | ESCALATE LAMINOPLASTY SYSTEM Stryker Spine | NQW |
| Jan 19, 2012 | K111719 | OASYS SPINAL SYSTEM Stryker Spine | KWP |
| Jul 28, 2011 | K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS Stryker Spine | GXZ |
| Apr 22, 2011 | K102606 | AVS ANCHOR-C CERVICAL CAGE SYSTEM Stryker Spine | OVE |
| Nov 9, 2010 | K101183 | MODIFICATION TO: OASYS SYSTEM Stryker Spine | KWP |
| Aug 24, 2010 | K102235 | MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM Stryker Spine | NKB |
| Aug 12, 2010 | K101051 | AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX Stryker Spine | MAX |
| Aug 11, 2010 | K100865 | AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX Stryker Spine | MAX |
| Jul 8, 2010 | K101144 | MODIFICATION TO:RADIUS SPINAL SYSTEM Stryker Spine | NKB |
| Apr 12, 2010 | K100737 | MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM Stryker Spine | NKB |
| Mar 18, 2010 | K093670 | MODIFICATION TO: OASYS SYSTEM Stryker Spine | MNH |
| Dec 3, 2009 | K092605 | XIA 4.5 SPINAL SYSTEM Stryker Spine | NKB |
| Sep 25, 2009 | K092631 | MANTIS REDUX SPINAL SYSTEM Stryker Spine | NKB |
| Sep 25, 2009 | K091946 | VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX Stryker Spine | MQP |
| Jun 24, 2009 | K091291 | XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD Stryker Spine | NKB |
| Apr 1, 2009 | K083393 | XIA 3 SPINAL SYSTEM Stryker Spine | NKB |
| Oct 7, 2008 | K082608 | RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 Stryker Spine | NKB |
| Jun 9, 2008 | K080773 | THOR ANTERIOR PLATING SYSTEM Stryker Spine | KWQ |
| Apr 30, 2008 | K080928 | XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS Stryker Spine | NKB |
| Mar 6, 2008 | K073470 | AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX Stryker Spine | MAX |
| Feb 14, 2008 | K080143 | MODIFICATION TO STRYKER SPINE OASYS SYSTEM Stryker Spine | MNI |
| Feb 13, 2008 | K073437 | THOR ANTERIOR PLATING SYSTEM Stryker Spine | KWQ |
| Oct 5, 2007 | K072568 | MODIFICATION TO OASYS SYSTEM Stryker Spine | KWP |
| Aug 27, 2007 | K071373 | STRYKER SPINE XIA III SPINAL SYSTEM Stryker Spine | NKB |
| Jul 13, 2007 | K070631 | DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM Stryker Spine | NKB |
| Mar 22, 2007 | K063430 | ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM Stryker Spine | KWQ |
| Dec 11, 2006 | K063428 | XIA STAINLESS STEEL SPINAL SYSTEM Stryker Spine | NKB |
| Nov 22, 2006 | K062270 | RADIUS SPINAL SYSTEM Stryker Spine | NKB |
| Oct 24, 2006 | K062853 | MODIFICATION TO STRYKER SPINE OASYS SYSTEM Stryker Spine | MNI |
Newest 50 of 75.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 22mm; Catalog 48019140. Open, Classified |
OVD | K201585 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Open, Classified |
OVD | K201585 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. Open, Classified |
OVD | K201585 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Open, Classified |
OVD | K201585 |
| Sep 23, 2024 | Stryker Spine AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at Open, Classified |
OVE | K102606 |
| Dec 21, 2023 | Stryker Spine LITe Decompression Snake Arm, REF 48080230 Open, Classified |
LXH | None listed |
| May 18, 2021 | Stryker Spine Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979 Terminated |
NDN | K080108 |
| May 18, 2021 | Stryker Spine Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 Terminated |
NDN | K080108 |
| Mar 11, 2021 | Stryker Spine Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plu Terminated |
MAX | None listed |
| Aug 13, 2018 | Stryker Spine AVS Aria Cage, Catalog Number 48753212
Product Usage:
The Stryker Spine AVS ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with d Terminated |
MAX | K151726 |
| Dec 18, 2015 | Stryker Spine Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France
Used to facilitate insertion of the Aero-AL cage into the disc space. Terminated |
LXH | None listed |
| Dec 16, 2015 | Stryker Spine AccuLIF PL Tubing Set and AccuLIF TL Tubing Set
AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301 Terminated |
MAX | K143616 |
| Nov 5, 2015 | Stryker Spine Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument. Terminated |
LXH | None listed |
| Sep 25, 2015 | Stryker Spine Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients. Terminated |
NKB | None listed |
| Dec 16, 2014 | Stryker Spine Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile.
Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors a Terminated |
LXH | None listed |
| Sep 11, 2014 | Stryker Spine Specialty Aria Inserter, REF IS3021ARI, Non-Sterile,
This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System of Terminated |
LXH | None listed |
| Sep 11, 2014 | Stryker Spine Stryker Aria Implant Inserter, REF 48758500,
This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers imp Terminated |
LXH | None listed |
| Feb 25, 2014 | Stryker Spine Specialty Straight Static Inserter Assembly
Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Terminated |
LXH | None listed |
| Nov 21, 2013 | Stryker Spine Stryker
1) XIA Torque Wrench
2) XIA 3 Torque Wrench
3) XIA Elegance Short Torque Wrench
Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30
http://www.stryk Terminated |
LXH | None listed |
| Aug 22, 2013 | Stryker Spine Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long
5) Mini.
Allows for positioning directly on the midline keel of the occiput. Terminated |
KWP | K093670 |
| Feb 28, 2013 | Stryker Spine Stryker XIA 3 Iliac Screwdriver, 3-PCS.
The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrume Terminated |
LXH | None listed |
| Nov 19, 2012 | Stryker Spine SPECIALTY AUDIBLE TORQUE WRENCH, XIA
IS2217XLP
MFG BY: STRYKER SPINE
2 PEARL COURT
ALLENDALE NJ 07401-1677
The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the bl Terminated |
LXH | None listed |
| Nov 19, 2012 | Stryker Spine Stryker MANTIS TORQUE WRENCH
REF 48287028
Manufactured by:
Stryker pine SAS
Z.I MARTICOT-33610-CESTAS-FRANCE
+33 (0)5.57.97.06.30
http://www.stryker.com
Distributed in the USA by:
Stryker Spine,
2 Terminated |
LXH | None listed |
| Nov 19, 2012 | Stryker Spine Stryker XIA 3 TORQUE WRENCH
REF 48237028
Manufactured by:
Stryker pine SAS
Z.I MARTICOT-33610-CESTAS-FRANCE
+33 (0)5.57.97.06.30
http://www.stryker.com
Distributed in the USA by:
Stryker Spine,
2 P Terminated |
LXH | None listed |
| Oct 29, 2012 | Stryker Spine Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm,
Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France
+33 (0) 5.57.97.06.30
http://www.stryker.com
Distributed in the USA by Stryker Spi Terminated |
LXH | None listed |
| Aug 22, 2012 | Stryker Spine The Instructions For Use for the following:
Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW
Stryker TRIO+ 5.5 Terminated |
MNI | K062698 |
| Aug 9, 2012 | Stryker Spine Stryker Reliance AL Implant Blocker (Various sizes)
The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region Terminated |
MDM | None listed |
| Aug 7, 2012 | Stryker Spine LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401.
Provid Terminated |
GAD | None listed |
| Jul 19, 2012 | Stryker Spine Stryker AVS Navigator Trials 6mm-15mm
Manufactured by:
Stryker Spine SAS
Z.1 Marticot-33610-Cestas -France
+33 (0) 5.57.97.06.30
http;//www.stryker.com
Distributed in the USA by
Stryker Spine
2 Pear Terminated |
LXH | None listed |
| Jun 5, 2012 | Stryker Spine Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026.
Product Usage: :
Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: Terminated |
NKB | K071373 |
| Nov 8, 2011 | Stryker Spine Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA
S Terminated |
HSB | None listed |
| Feb 15, 2011 | Stryker Spine Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products:
Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalo Terminated |
LXH | None listed |
| Jan 12, 2011 | Stryker Spine Disc Space Distractor
Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677
Used to assist in spinal fusions. It is to be placed between the vert Terminated |
LXH | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Jul 8, 2010 | Stryker Spine Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407.
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401.
Intended f Terminated |
MDM | None listed |
| Apr 12, 2010 | Stryker Spine Stryker Reflex Hybrid Screw Extractor Inner Shaft;
Not Sterile;
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ.
The threaded Terminated |
KWQ | K062310 |
| Apr 12, 2010 | Stryker Spine Stryker Reflex Hybrid Screw Extractor;
Not Sterile: Manufactured by: Stryker Spine SAS,
Cestas, France; Distributed in the USA by: Stryker Spine, 2 Pearl Court, Allendale, NJ.
The threaded tip of the Terminated |
KWQ | K062310 |
| Feb 24, 2010 | Stryker Spine Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565.
Not Sterile;
Manufactured by Stryker Spine, SA, Cestas, France.
Distributed in the USA by Stryker Spine, Allendale, NJ
Inte Terminated |
NKB | K083393 |
| Feb 16, 2010 | Stryker Spine Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N Terminated |
LHX | None listed |
| Feb 16, 2010 | Stryker Spine Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N Terminated |
LXH | None listed |
Newest 50 of 99.