# Bodycad Laboratories, Inc.

- Location (FDA's records): Quebec, CA
- FDA decisions: 16 (2017–2025): 16 510(k) clearances
- Product codes: HSX (7), HRS (6), PBF (3)
- 510(k) review time since 2016: median 87 days, against 90 for FDA's reviews in the same codes and years (7 of 16 faster)
- Predicates its devices cite: 30 (18 its own); citations of its devices by later devices: 20 (18 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
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Conformis, Inc.: 2 (https://510kreport.com/company/conformis)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Additive Orthopaedics, LLC: 1 (https://510kreport.com/company/additive-orthopaedics)
- Materialise NV: 1 (https://510kreport.com/company/materialise)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Mako Surgical Corp.: 1 (https://510kreport.com/company/mako-surgical)

## Firms that cite its devices most
- Implantcast GmbH: 2 (https://510kreport.com/company/implantcast)

## Its most-cited devices
- K163700: Bodycad Unicompartmental Knee System (2017), cited by 4
- K191150: Bodycad Unicompartmental Knee System (2019), cited by 3
- K181302: Bodycad Unicompartmental Knee System (2019), cited by 3
- K203697: BC Reflex Uni Knee System (2021), cited by 2
- K241356: Fine Osteotomy™ (2024), cited by 2
- K250923: Fine Osteotomy™ (2025), cited by 1

## Recent decisions
- K253300: Fine Osteotomy™ (Oct 28, 2025)
- K250394: Fine TTO™ (Oct 21, 2025)
- K250923: Fine Osteotomy™ (Aug 21, 2025)
- K241356: Fine Osteotomy™ (Sep 5, 2024)
- K240703: Fine Osteotomy™ (Apr 12, 2024)
- K240066: Fine Osteotomy™ (Feb 9, 2024)
- K231314: Fine Osteotomy™ (Jun 2, 2023)
- K212307: BC Reflex Uni Knee System (Oct 12, 2021)

Source page: https://510kreport.com/company/bodycad-laboratories
