# Implantcast GmbH

- Location (FDA's records): Buxtehude, DE
- FDA decisions: 20 (2017–2026): 20 510(k) clearances
- Product codes: LZO (10), KWT (3), MEH (2), KWY (1), HSX (1), JWH (1), HSD (1), OQI (1)
- 510(k) review time since 2016: median 224 days, against 122 for FDA's reviews in the same codes and years (6 of 15 faster)
- Predicates its devices cite: 92 (42 its own); citations of its devices by later devices: 42 (42 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zimmer, Inc.: 10 (https://510kreport.com/company/zimmer)
- Aesculap, Inc.: 5 (https://510kreport.com/company/aesculap)
- Medacta International S.A.: 5 (https://510kreport.com/company/medacta-international)
- Howmedica Osteonics Corp.: 5 (https://510kreport.com/company/howmedica-osteonics)
- Biomet Manufacturing Corp: 4 (https://510kreport.com/company/biomet-manufacturing)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Bodycad Laboratories, Inc.: 2 (https://510kreport.com/company/bodycad-laboratories)

## Its most-cited devices
- K163577: Ecofit® Hip System (2017), cited by 7
- K180263: EcoFit Vit E Acetabular System (2018), cited by 5
- K203420: EcoFit® Hip System (2021), cited by 4
- K191569: Implantcast ic-Bipolar Head System (2019), cited by 3
- K222482: AGILON XO Shoulder System (2022), cited by 3
- K210678: implaFit® hip stems (2022), cited by 3

## Recent decisions
- K252451: EPORE® XO cup system (Apr 24, 2026)
- K260037: implantcast Packaging System Update (Mar 30, 2026)
- K252401: implaFit® short stems (Mar 12, 2026)
- K241944: AGILON® XO Shoulder Replacement System (Mar 10, 2025)
- K240391: MUTARS® femoral stem cemented 160 mm and 200 mm (Oct 24, 2024)
- K234044: ACS® LD FB Knee System (Sep 6, 2024)
- K240834: EcoFit® short stem cementless cpTi (Jun 3, 2024)
- K231657: AGILON® XO Shoulder Replacement System (Feb 16, 2024)

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