# Aesculap Implant Systems, LLC

- Location (FDA's records): Center Valley, PA
- FDA decisions: 51 (2007–2022): 51 510(k) clearances
- Names in FDA's records: Aesculap Implant Systems, LLC (22); Aesculap Implant Systems, Inc. (22); Aesculap Implant Systems (7)
- Product codes: NKB (9), JWH (8), LZO (7), MAX (3), OLO (3), MEH (3), KWQ (2), NKG (2), HRY (2), HRS (2), OVD (2), ODP (1)
- 510(k) review time since 2016: median 159 days, against 108 for FDA's reviews in the same codes and years (0 of 7 faster)
- Predicates its devices cite: 175 (39 its own); citations of its devices by later devices: 104 (39 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aesculap, Inc.: 46 (https://510kreport.com/company/aesculap)
- Aesculap Implant System, Inc.: 20 (https://510kreport.com/company/aesculap-implant-system)
- Zimmer, Inc.: 12 (https://510kreport.com/company/zimmer)
- Depuy Spine, Inc.: 11 (https://510kreport.com/company/depuy-spine)
- Spinal Innovations, LLC: 8 (https://510kreport.com/company/spinal-innovations)
- Spinal Elements, Inc.: 4 (https://510kreport.com/company/spinal-elements)
- Biomet Spine: 3 (https://510kreport.com/company/biomet-spine)
- Hayes Medical, Inc.: 2 (https://510kreport.com/company/hayes-medical)

## Firms that cite its devices most
- Aesculap Implants Systems, LLC: 13 (https://510kreport.com/company/aesculap-implants-systems)
- Aesculap Implant System, Inc.: 6 (https://510kreport.com/company/aesculap-implant-system)
- Omni Life Science, Inc.: 5 (https://510kreport.com/company/omni-life-science)
- Spineology, Inc.: 4 (https://510kreport.com/company/spineology)
- Medacta International S.A.: 4 (https://510kreport.com/company/medacta-international)
- Tyber Medical, LLC: 3 (https://510kreport.com/company/tyber-medical)
- Medyssey Co, Ltd.: 3 (https://510kreport.com/company/medyssey)
- Consensus Orthopedics, Inc.: 2 (https://510kreport.com/company/consensus-orthopedics)

## Its most-cited devices
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), cited by 12
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System (2009), cited by 8
- K071916: Metha Hip System (2008), cited by 7
- K123352: S4 Spinal System (2012), cited by 6
- K071945: S4 Spinal System (2007), cited by 5
- K100623: Aesculap Implant Systems S4 Spinal System (2010), cited by 5

## Recent decisions
- K213871: Ennovate Cervical Spinal and Occiput System (Jul 1, 2022)
- K210963: ENNOVATE Spinal System (Jul 19, 2021)
- K180433: Ennovate® (Apr 26, 2018)
- K162134: ENNOVATE Spinal System (Dec 14, 2016)
- K153700: Aesculap (R) Implant Systems (AIS) S4 Navigation Instruments (Jul 8, 2016)
- K153629: ArcadiusXP C Spinal System (May 25, 2016)
- K153396: Aesculap OrthoPilot Next Generation (May 16, 2016)
- K151938: S4 Cervical Spinal and Occiput Systems (Oct 21, 2015)

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