# Aesculap, Inc.

- Location (FDA's records): Center Valley, PA
- FDA decisions: 219 (1991–2026): 219 510(k) clearances
- Names in FDA's records: Aesculap, Inc. (208); Aesculap (10); Aesculap, Ltd. (1)
- Product codes: GEI (18), JXG (14), GCJ (14), KCT (13), KWQ (11), HCH (10), GWG (7), GAM (7), FRG (6), JWH (6), HCI (5), HBE (5)
- 510(k) review time since 2016: median 154 days, against 133 for FDA's reviews in the same codes and years (9 of 23 faster)
- Predicates its devices cite: 389 (154 its own); citations of its devices by later devices: 369 (154 its own)
- Recalls linked to its devices: 56 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 14 (https://510kreport.com/company/howmedica-osteonics)
- ETHICON, Inc.: 11 (https://510kreport.com/company/ethicon)
- Kinamed, Inc.: 9 (https://510kreport.com/company/kinamed)
- Aesculap Instruments Corp.: 8 (https://510kreport.com/company/aesculap-instruments)
- Osteonics Corp.: 7 (https://510kreport.com/company/osteonics)
- Advanced Biosearch Assn.: 7 (https://510kreport.com/company/advanced-biosearch-assn)
- The Anspach Effort, Inc.: 6 (https://510kreport.com/company/anspach-effort)
- J.B.S., S.A.: 5 (https://510kreport.com/company/jbs)

## Firms that cite its devices most
- Aesculap Implant Systems, LLC: 46 (https://510kreport.com/company/aesculap-implant-systems)
- Aesculap Implant System, Inc.: 15 (https://510kreport.com/company/aesculap-implant-system)
- Aesculap Implants Systems, LLC: 9 (https://510kreport.com/company/aesculap-implants-systems)
- Implantcast GmbH: 5 (https://510kreport.com/company/implantcast)
- L&K BIOMED Co., Ltd.: 4 (https://510kreport.com/company/l-k-biomed)
- Ulrich GmbH & Co. KG: 4 (https://510kreport.com/company/ulrich)
- Bioplate, Inc.: 3 (https://510kreport.com/company/bioplate)
- Jeil Medical Corporation: 3 (https://510kreport.com/company/jeil-medical)

## Its most-cited devices
- K042344: Excia Total Hip System (2005), cited by 17
- K050979: S4 Spinal System (2005), cited by 12
- K974706: Aesculap Abc Cervical Plating System (1998), cited by 9
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), cited by 9
- K000486: Abc Cervical Plating System (2000), cited by 9
- K040191: Bicontact Hip Stem and Femoral Head (2004), cited by 8

## Recent decisions
- K260044: Ventricular Catheters, Thomale Catheter (Oct 2, 2026)
- K242762: Aesculap Aicon® Series Container System (May 13, 2025)
- K242003: XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (Dec 16, 2024)
- K223596: SQ.line KERRISON (Jun 29, 2023)
- K214041: Aesculap AICON Container (Dec 30, 2022)
- K211572: Aesculap Slim Clip Applier (Dec 13, 2021)
- K203739: ELAN 4 Electro Motor System (Aug 24, 2021)
- K202391: DIR 800 (Jan 21, 2021)

Source page: https://510kreport.com/company/aesculap