# Pixee Medical

- Location (FDA's records): Besançon, FR
- FDA decisions: 7 (2021–2026): 7 510(k) clearances
- Names in FDA's records: Pixee Medical (6); Pixee Medical S.A.S. (1)
- Product codes: SBF (6), LLZ (1)
- 510(k) review time since 2016: median 147 days, against 123 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 9 (5 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 Cas: 1 (https://510kreport.com/company/zimmer-cas)
- Augmedics, Ltd.: 1 (https://510kreport.com/company/augmedics)
- FH Industrie: 1 (https://510kreport.com/company/fh-industrie)

## Firms that cite its devices most
- Avatar Medical: 2 (https://510kreport.com/company/avatar-medical)
- Mr Surgical Solutions, LLC: 1 (https://510kreport.com/company/mr-surgical-solutions)
- Polarisar, Inc.: 1 (https://510kreport.com/company/polarisar)

## Its most-cited devices
- K243975: Knee+ (2025), cited by 2
- K213922: FX SPS (2022), cited by 2
- K220104: Knee+ (2022), cited by 2
- K202750: Knee+ (2021), cited by 1
- K233899: Knee+ (2024), cited by 1
- K230789: Knee+ (2023), cited by 1

## Recent decisions
- K253805: Knee+ (Apr 24, 2026)
- K243975: Knee+ (Mar 20, 2025)
- K233899: Knee+ (Mar 8, 2024)
- K230789: Knee+ (Apr 21, 2023)
- K220104: Knee+ (Sep 1, 2022)
- K213922: FX SPS (Jul 22, 2022)
- K202750: Knee+ (Apr 21, 2021)

Source page: https://510kreport.com/company/pixee-medical