510(k) Report

FDA applicant

Bodycad Laboratories, Inc.

Quebec, CA16 decisions2017–20250 recalls

FDA records 16 decisions for Bodycad Laboratories, Inc. (Quebec, CA) from 2017 to 2025: 16 510(k) clearances. Most are in product codes HSX (Prosthesis, Knee, Femorotibial…) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 18 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Bodycad Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2017: 12019: 32020: 12021: 42023: 12024: 32025: 3
2017high 4 (2021) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Bodycad Laboratories, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bodycad Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer7decisions
  • HRSPlate, Fixation, Bone6decisions
  • PBFOrthopaedic Surgical Planning And Instrument Guides3decisions

How long do its 510(k) reviews take?

Since 2016, its 16 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 7 of its 16 were faster than that.

Whose devices does it build on?

Its devices cite 30 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 18 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 20174cite it
  • K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 20193cite it
  • K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 20193cite it
  • K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 20212cite it
  • K241356Fine Osteotomy™Bodycad Laboratories, Inc. · 20242cite it
  • K250923Fine Osteotomy™Bodycad Laboratories, Inc. · 20251cites it

What has FDA decided for it lately?

  • K253300Fine Osteotomy™Bodycad Laboratories, Inc. · 2025
  • K250394Fine TTO™Bodycad Laboratories, Inc. · 2025
  • K250923Fine Osteotomy™Bodycad Laboratories, Inc. · 2025
  • K241356Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
  • K240703Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
  • K240066Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
  • K231314Fine Osteotomy™Bodycad Laboratories, Inc. · 2023
  • K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021

All 16 as Bodycad Laboratories, Inc. →