Company · US
Aesculap Implant Systems LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2022. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (0 in 12 months)
73recalls (0 in 12 months)
45recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 17 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 14 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 11 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 10 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 7 |
| FZP | Clip, Implantable | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 |
| LXH | Orthopedic Manual Surgical Instrument | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 2 |
| GWG | Endoscope, Neurological | 2 |
| HRS | Plate, Fixation, Bone | 2 |
| HWT | Template | 2 |
| HXK | Holder, Needle; Orthopedic | 2 |
| HXW | Bender | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2022 | K213871 | Ennovate Cervical Spinal and Occiput System Aesculap Implant Systems, LLC | NKG |
| Jul 19, 2021 | K210963 | ENNOVATE Spinal System Aesculap Implant Systems, LLC | NKB |
| Apr 26, 2018 | K180433 | ENNOVATE® Aesculap Implant Systems, LLC | NKB |
| Dec 14, 2016 | K162134 | ENNOVATE Spinal System Aesculap Implant Systems, LLC | NKB |
| Jul 8, 2016 | K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments Aesculap Implant Systems, LLC | OLO |
| May 25, 2016 | K153629 | ArcadiusXP C Spinal System Aesculap Implant Systems, Inc. | OVE |
| May 16, 2016 | K153396 | Aesculap OrthoPilot Next Generation Aesculap Implant Systems, LLC | OLO |
| Oct 21, 2015 | K151938 | S4 Cervical Spinal and Occiput Systems Aesculap Implant Systems, LLC | NKG |
| Aug 13, 2015 | K151056 | Aesculap T-Space PEEK and XP Spinal System Aesculap Implant Systems, LLC | MAX |
| May 29, 2015 | K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System Aesculap Implant Systems, LLC | JWH |
| Feb 24, 2015 | K141694 | AESCULAP ORTHOPILOT NEXT GENERATION Aesculap Implant Systems, LLC | OLO |
| Feb 9, 2015 | K150062 | Excia Total Hip System Aesculap Implant Systems, LLC | LZO |
| Nov 21, 2014 | K143106 | VEGA Knee System Aesculap Implant Systems, LLC | JWH |
| Jul 21, 2014 | K140915 | EXCIA TOTAL HIP SYSTEM Aesculap Implant Systems, LLC | LZO |
| Mar 25, 2014 | K140452 | VEGA KNEE SYSTEM Aesculap Implant Systems | JWH |
| Jan 22, 2014 | K132421 | AESCULAP PEEK XP SPINAL IMPLANT SYSTEM Aesculap Implant Systems, Inc. | MAX |
| Oct 17, 2013 | K131167 | UNIVATION Aesculap Implant Systems, LLC | HRY |
| Mar 12, 2013 | K123939 | S4 SPINAL SYSTEM Aesculap Implant Systems, Inc. | NKB |
| Dec 17, 2012 | K120955 | COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM Aesculap Implant Systems, LLC | JWH |
| Dec 12, 2012 | K123352 | S4 SPINAL SYSTEM Aesculap Implant Systems, Inc. | NKB |
| Sep 11, 2012 | K121801 | QUINTEX CERVICAL PLATING SYSTEM Aesculap Implant Systems, LLC | KWQ |
| Jul 27, 2012 | K121879 | VEGA KNEE SYSTEM Aesculap Implant Systems | JWH |
| Mar 19, 2012 | K112682 | METHA HIP SYSTEM Aesculap Implant Systems, LLC | LZO |
| Aug 4, 2011 | K111122 | AESCULAP SIBD XP SPINAL SYSTEM Aesculap Implant Systems, Inc. | OVD |
| Jun 15, 2011 | K110864 | BIOSPINE VBR SYSTEM Aesculap Implant Systems, LLC | MQP |
| Dec 21, 2010 | K102057 | TARGON FN SYSTEM Aesculap Implant Systems, LLC | KTT |
| Dec 20, 2010 | K101815 | ENDURO KNEE SYSTEM Aesculap Implant Systems | KRO |
| Dec 9, 2010 | K102424 | PREVISION HIP SYSTEM WITH RECON RING Aesculap Implant Systems, LLC | MEH |
| Dec 2, 2010 | K103284 | LAMINOPLASY PLATING SYSTEM Aesculap Implant Systems, Inc. | NQW |
| Nov 24, 2010 | K102505 | HTO PLATING SYSTEM Aesculap Implant Systems, LLC | HRS |
| Sep 2, 2010 | K100243 | QUINTEX CERVICAL PLATING SYSTEM Aesculap Implant Systems, LLC | KWQ |
| Jul 20, 2010 | K100802 | AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM Aesculap Implant Systems, Inc. | OVD |
| Jun 9, 2010 | K100623 | AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM Aesculap Implant Systems | NKB |
| Sep 22, 2009 | K092143 | EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM Aesculap Implant Systems, Inc. | MEH |
| Jul 2, 2009 | K083004 | MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM Aesculap Implant Systems, Inc. | NKB |
| Apr 24, 2009 | K090299 | BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS Aesculap Implant Systems | LZO |
| Apr 20, 2009 | K090657 | MODIFICATION TO: S4 SPINAL SYSTEM Aesculap Implant Systems | NKB |
| Mar 4, 2009 | K083311 | AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM Aesculap Implant Systems, Inc. | ODP |
| Jan 15, 2009 | K083495 | MODIFICATION TO: METHA HIP SYSTEM Aesculap Implant Systems, Inc. | LZO |
| Nov 20, 2008 | K082991 | BIOLOX DELTA CERAMIC FEMORAL HEAD Aesculap Implant Systems, Inc. | LZO |
| Sep 22, 2008 | K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM Aesculap Implant Systems, Inc. | HRY |
| Sep 9, 2008 | K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD Aesculap Implant Systems, Inc. | LWJ |
| Sep 4, 2008 | K080992 | AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM Aesculap Implant Systems, Inc. | HRS |
| Aug 7, 2008 | K081973 | METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM Aesculap Implant Systems, Inc. | LZO |
| Jun 2, 2008 | K071916 | METHA HIP SYSTEM Aesculap Implant Systems, Inc. | MEH |
| May 1, 2008 | K071983 | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE Aesculap Implant Systems, Inc. | MAX |
| Feb 6, 2008 | K072899 | ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 Aesculap Implant Systems, Inc. | HAW |
| Sep 20, 2007 | K071945 | S4 SPINAL SYSTEM Aesculap Implant Systems | NKB |
| Sep 14, 2007 | K071499 | COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY Aesculap Implant Systems, Inc. | JWH |
| Aug 21, 2007 | K070981 | SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) Aesculap Implant Systems, Inc. | JWH |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2023 | Aesculap Implant Systems LLC For intraventricular indications mainly used for operations within the brain ventricles.
Product Code: FF399R Open, Classified |
GWG | K983365 |
| Jul 14, 2023 | Aesculap Implant Systems LLC Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable
Article Number: MD610 Open, Classified |
HXK | None listed |
| May 5, 2023 | Aesculap Implant Systems LLC Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in Open, Classified |
GEI | K183180 |
| Apr 25, 2023 | Aesculap Implant Systems LLC Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for plac Open, Classified |
FSM | None listed |
| Jul 15, 2022 | Aesculap Implant Systems LLC Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine.
Article Number: 52758014 Open, Classified |
NKB | K180433 |
| Jul 14, 2022 | Aesculap Implant Systems LLC Aeos Robotic Digital Microscope with software versions 2.7 or earlier
Article Number: PV010 Terminated |
FSO | None listed |
| Oct 25, 2021 | Aesculap Implant Systems LLC MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 Terminated |
HXX | None listed |
| Jun 30, 2021 | Aesculap Implant Systems LLC LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. Terminated |
HXW | None listed |
| Jun 30, 2021 | Aesculap Implant Systems LLC RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. Terminated |
HXW | None listed |
| Apr 16, 2021 | Aesculap Implant Systems LLC PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US
Catalog Number: FG-000001-13 Terminated |
FZP | K202124 |
| Apr 16, 2021 | Aesculap Implant Systems LLC PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Catalog Number: FC700SU Terminated |
FZP | K202124 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System Tray Sysem knee implant devices as follows:
Tray Number/Set Name/Set Number
NM1090R Navigation Set ST0560;
NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM;
NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM;
NO182Z AS UNIVATION XF FEMUR CEMENTED Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM;
NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM;
NO158Z AS UNIVATION XF TIBIA CEMENTED Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM;
NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM;
NL496 UNIVATION F MENISCAL COMP.T3 Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM;
NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM;
NL490 UNIVATION F MENISCAL COMP.T3 R Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM;
NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM;
NL484 UNIVATION F MENISCAL COMP.T3 RM/ Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM;
NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM;
NL478 UNIVATION F MENISCAL COMP.T3 RM/ Terminated |
HRY | K081293 K131167 |
| Mar 19, 2021 | Aesculap Implant Systems LLC Univation X System knee implant devices as follows:
Catalog/Product:
NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;
NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM;
NL472 UNIVATION F MENISCAL COMP.T3 RM Terminated |
HRY | K081293 K131167 |
| Feb 19, 2021 | Aesculap Implant Systems LLC Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 Completed |
FSO | None listed |
| Nov 18, 2020 | Aesculap Implant Systems LLC ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Terminated |
LXH | None listed |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Jul 13, 2020 | Aesculap Implant Systems LLC ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Terminated |
LXH | None listed |
| Apr 1, 2020 | Aesculap Implant Systems LLC PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10 Completed |
KOA | None listed |
| Apr 1, 2020 | Aesculap Implant Systems LLC PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10 Completed |
KOA | None listed |
| Jan 21, 2020 | Aesculap Implant Systems LLC COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.
NR068K
NR068Z
NR070K
NR070Z
NR071K
NR071Z
NR072K
NR072Z
NR073K
NR073Z
NR074K
NR074Z
NR075K
NR075Z
NR076K
NR076Z Terminated |
JWH | K083772 |
| Jan 21, 2020 | Aesculap Implant Systems LLC AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos.
NN058Z
NN070Z
NN071Z
NN072Z
NN073Z
NN074Z
NN075Z
NN076Z
NN077Z
NN078Z
NN079Z
NN470Z
NN471Z
NN472Z
NN473Z
NN474Z
Terminated |
JWH | K071220 |
| Jan 21, 2020 | Aesculap Implant Systems LLC COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos.
NN469K
NN470K
NN471K
NN472K
NN473K
NN474K
NN475K
NN476K
NN477K
NN478K
NN479K
Product Usage: Tibia-Plateaus are pa Terminated |
JWH | K053390 |
| Jan 21, 2020 | Aesculap Implant Systems LLC COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos.
NN081K
NN082K
NN083K
NN084K
NN085K
NN086K
NN087K
NN088K
NN089K
Product Usage: Tibia-Plateaus are part of implants Terminated |
JWH | K030367 |
| Jan 21, 2020 | Aesculap Implant Systems LLC Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K
NN070K
NN071K
NN072K
NN073K
NN074K
NN075K
NN076K
NN077K
NN078K
NN079K
Product Usage:Tibia-Plateaus are par Terminated |
JWH | K022672 |
| Nov 12, 2019 | Aesculap Implant Systems LLC ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery. Completed |
LXH | None listed |
| Oct 1, 2019 | Aesculap Implant Systems LLC Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R. Terminated |
PUI | None listed |
| Sep 25, 2019 | Aesculap Implant Systems LLC AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle Terminated |
HXK | None listed |
| Aug 7, 2019 | Aesculap Implant Systems LLC CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM
REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. Terminated |
GEI | K093075 |
| Aug 7, 2019 | Aesculap Implant Systems LLC CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. Terminated |
GEI | K093075 |
| Feb 16, 2018 | Aesculap Implant Systems LLC Strauss Penis Clamp 130MM/General Instruments Terminated |
FHA | None listed |
| Feb 16, 2018 | Aesculap Implant Systems LLC Doyen-Collin Mouth Gag 120MM/ General Instruments Terminated |
KBN | None listed |
| Feb 15, 2018 | Aesculap Implant Systems LLC The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery. Terminated |
HBB | None listed |
| Feb 15, 2018 | Aesculap Implant Systems LLC JS Series SterilContainer S2 System Terminated |
KCT | None listed |
| Feb 12, 2018 | Aesculap Implant Systems LLC NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468)
The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used Terminated |
HWT | None listed |
| Jan 22, 2018 | Aesculap Implant Systems LLC DS Titanium Ligation Clip Appliers, used in laparoscopic surgery Terminated |
FZP | K080753 K102081 |
| Jan 22, 2018 | Aesculap Implant Systems LLC DS Titanium Ligation Clip, used in laparoscopic surgery Terminated |
FZP | K080753 K102081 |
| Sep 21, 2017 | Aesculap Implant Systems LLC proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System
Shunt, central nervous system and components Terminated |
JXG | K161853 |
| Sep 5, 2017 | Aesculap Implant Systems LLC ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5
ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5
ELAN 4 1-RING NEURO CUTTER SOFT D3.0
ELAN Terminated |
HBE | None listed |
| Sep 5, 2017 | Aesculap Implant Systems LLC ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5
ELAN 4 1-RING TWIST DRILL D2.0
ELAN 4 2-RING TWIST DRILL D1,0/4,0MM
ELAN 4 2-RING TWIST DRILL D1,1/4,0MM
ELAN 4 2-RING TWIST DRILL D1,2/4,0MM
ELAN 4 2-RING Terminated |
HBE | None listed |
Newest 50 of 73.