# Zimmer Switzerland Manufacturing GmbH

- Location (FDA's records): Winterthur, CH
- FDA decisions: 4 (2021–2025): 4 510(k) clearances
- Product codes: HSB (2), JWH (1), HRS (1)
- 510(k) review time since 2016: median 70 days, against 101 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 16 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zimmer, Inc.: 13 (https://510kreport.com/company/zimmer)
- Depuy Ace: 2 (https://510kreport.com/company/depuy-ace)

## Firms that cite its devices most
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)

## Its most-cited devices
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), cited by 2

## Recent decisions
- K253749: Affixus® Natural Nail® Proximal Humeral System (Dec 12, 2025)
- K241754: NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate (Aug 15, 2024)
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (Aug 9, 2023)
- K212129: Persona® Personalized Knee System (Sep 28, 2021)

Source page: https://510kreport.com/company/zimmer-switzerland-manufacturing
