Company ยท US
Stryker Howmedica Osteonics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2006. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
528recalls (0 in 12 months)
360recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 88 |
| LXH | Orthopedic Manual Surgical Instrument | 72 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 64 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 51 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 43 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 37 |
| HWC | Screw, Fixation, Bone | 30 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 21 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | 19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 18 |
| HTW | Bit, Drill | 8 |
| HWA | Impactor | 7 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 5 |
| HRS | Plate, Fixation, Bone | 4 |
| HTO | Reamer | 4 |
| HWT | Template | 4 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 4 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 3 |
| JDS | Nail, Fixation, Bone | 3 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2017 | Stryker Howmedica Osteonics Corp. Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241
Product Usage:
Intended for fixation of fractures, joint contractures, fusions, limb Terminated |
KTT | K153377 |
| Dec 2, 2016 | Stryker Howmedica Osteonics Corp. Reunion TSA Peg Alignment Sound
Catalog #5901-1038
The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg a Terminated |
LXH | None listed |
| Nov 9, 2016 | Stryker Howmedica Osteonics Corp. GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R
Intended for the temporar Terminated |
NDE | None listed |
| Oct 7, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp. Terminated |
HWA | K153345 |
| Sep 13, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10)
The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for th Terminated |
MBH | K033972 |
| Sep 13, 2016 | Stryker Howmedica Osteonics Corp. Femoral Nail, A/R T2 Femur 011x280 mm
T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of Terminated |
HSB | K010801 |
| Sep 13, 2016 | Stryker Howmedica Osteonics Corp. Supracondylar Nail T2 SCN 09x300 mm
T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and close Terminated |
HSB | K023267 |
| Aug 29, 2016 | Stryker Howmedica Osteonics Corp. LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip repla Terminated |
JDI | K022077 |
| Aug 11, 2016 | Stryker Howmedica Osteonics Corp. Orthopedic manual surgical instrument
Usage:
Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and lo Terminated |
JDI | K110290 |
| Jun 23, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S
Product Usage:
Is a reusable instrument that is part of the Triathlon Primary total Terminated |
JWH | K143393 |
| Jun 23, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile,
Used to complement or replace the standard instruments used during the implantation of hip, knee, t Terminated |
MBH | K123486 |
| Jun 3, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile
Catalog Numbers 2199-2022, 2199-2028 and 2199-2032.
For use in total hip arthroplasty. Terminated |
LPH | K151264 |
| Apr 18, 2016 | Stryker Howmedica Osteonics Corp. VariAx Compression Plating System Terminated |
HWC | K130009 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 K-Wire, 3.2x400mm, Recon
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | K131365 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | K123604 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 K-Wire, 3x285 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, Gamma Guide Pin, 4x400 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | K123401 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, Gamma K-Wire 3.2x450 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | K063225 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 K-Wire 1.8 x 310 mm, Sterile
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
MAY | None listed |
| Dec 23, 2015 | Stryker Howmedica Osteonics Corp. Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. Terminated |
JDR | K031127 |
| Dec 2, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adapto Terminated |
JWH | K973164 |
| Nov 17, 2015 | Stryker Howmedica Osteonics Corp. Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm,
Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with P Terminated |
JDI | None listed |
| Nov 10, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component. Terminated |
LPH | K121308 |
| Nov 9, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capt Terminated |
JWH | K123486 |
| Sep 23, 2015 | Stryker Howmedica Osteonics Corp. Trident 10 degrees X3 Insert 36 mm ID
Catalog #623-10-36I
Hip implant component Terminated |
LPH | K033716 |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty. Terminated |
KXE | K061146 |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius. Terminated |
JDB | K102180 |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients. Terminated |
JDB | K070236 |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty. Terminated |
KXE | K061146 |
| Aug 20, 2015 | Stryker Howmedica Osteonics Corp. rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius. Terminated |
JDB | K102180 |
| Aug 14, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR
REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism. Terminated |
MBH | K141056 |
| Aug 10, 2015 | Stryker Howmedica Osteonics Corp. Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm
Product Usage:
The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat Terminated |
JWH | K141056 |
| Aug 10, 2015 | Stryker Howmedica Osteonics Corp. ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument.
Howmedica Osteonics Corp.
A Subsidiary of Stryker Corp.
Stry Terminated |
KWS | K103835 |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint Terminated |
JWH | K042993 K070095 |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Scorpio femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint. Terminated |
JWH | K030978 K042343 +2 |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
Hip prosthesis component. The RESTORATION Acet Terminated |
LPH | K102019 |
| May 14, 2015 | Stryker Howmedica Osteonics Corp. Kinemax Stem Extenders, 80 mm,
Product Usage:
Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (M Terminated |
JWH | K904208 |
| Mar 16, 2015 | Stryker Howmedica Osteonics Corp. Triathlon Distal Capture Assembly
Catalog No: 6541-1-723
The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resect Terminated |
MBH | K123486 |
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