BC Reflex Uni Knee System— 510(k) K203697

Name: FDA 510(k) clearance K203697
Creator: U.S. Food and Drug Administration
Published: 2021-03-12

Substantially Equivalent

Bodycad Laboratories, Inc.

FDA 510(k) clearance K203697 for BC Reflex Uni Knee System, Substantially Equivalent on 2021-03-12. Applicant: Bodycad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bodycad Laboratories, Inc.
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 2020-12-18
Decision date: 2021-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Quebec City, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSX

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K261609 — Freedom Partial Knee System2026-08-04
K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
K251771 — Cambridge Partial Knee2025-12-16
K251834 — Persona Partial Knee2025-08-15
K251618 — MOTO Partial Knee System Extension2025-07-24

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.