# Aesculap Implant System, Inc.

- Location (FDA's records): Center Valley, PA
- FDA decisions: 18 (2007–2014): 18 510(k) clearances
- Product codes: MQP (3), NKB (3), JWH (3), OLO (2), MAI (1), HWC (1), ODP (1), MEH (1), HAW (1), OQG (1), NQW (1)
- Predicates its devices cite: 54 (4 its own); citations of its devices by later devices: 49 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aesculap, Inc.: 15 (https://510kreport.com/company/aesculap)
- Brainlab AG: 6 (https://510kreport.com/company/brainlab)
- Aesculap Implant Systems, LLC: 6 (https://510kreport.com/company/aesculap-implant-systems)
- Depuy Spine, Inc.: 6 (https://510kreport.com/company/depuy-spine)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Ulrich GmbH & Co. KG: 2 (https://510kreport.com/company/ulrich)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Synthes: 1 (https://510kreport.com/company/synthes)

## Firms that cite its devices most
- Aesculap Implant Systems, LLC: 20 (https://510kreport.com/company/aesculap-implant-systems)
- CarboFix Orthopedics, Ltd.: 8 (https://510kreport.com/company/carbofix-orthopedics)
- Aesculap Implants Systems, LLC: 3 (https://510kreport.com/company/aesculap-implants-systems)
- Global Manufacturing Technology: 1 (https://510kreport.com/company/global-manufacturing-technology)
- Konigsee Implantate GmbH: 1 (https://510kreport.com/company/konigsee-implantate)
- X-Spine Systems, Inc.: 1 (https://510kreport.com/company/x-spine-systems)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Biomet Orthopedics, Inc.: 1 (https://510kreport.com/company/biomet-orthopedics)

## Its most-cited devices
- K130291: S4 Spinal System (2013), cited by 10
- K080584: Metha Short Stem Hip System (2008), cited by 9
- K101281: Vega Knee System (2010), cited by 5
- K083186: Aesculap Hydrolift VBR System (2010), cited by 4
- K112551: S4 Spinal System (2011), cited by 4
- K130887: S4C Navigation Instruments (2013), cited by 2

## Recent decisions
- K142707: AIS Odontoid Fracture Fixation System (Dec 19, 2014)
- K142150: Ais Modulift VBR System (Oct 29, 2014)
- K133802: Ais Modulift VBR System (Apr 17, 2014)
- K122783: Plasmafit Acetabular Cup and Vitelene Insert (Oct 30, 2013)
- K130887: S4C Navigation Instruments (Aug 13, 2013)
- K123909: Aesculap Cespace XP (Apr 15, 2013)
- K130291: S4 Spinal System (Apr 11, 2013)
- K122985: Columbus Revision Knee System (Oct 26, 2012)

Source page: https://510kreport.com/company/aesculap-implant-system
