Genius / Genuin Total Knee System— 510(k) K200765

Name: FDA 510(k) clearance K200765
Creator: U.S. Food and Drug Administration
Published: 2021-05-05

Substantially Equivalent

Biorad Medisys Pvt, Ltd.

FDA 510(k) clearance K200765 for Genius / Genuin Total Knee System, Substantially Equivalent on 2021-05-05. Applicant: Biorad Medisys Pvt, Ltd.. Device class: 2.

Clearance details

Applicant: Biorad Medisys Pvt, Ltd.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2020-03-24
Decision date: 2021-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pune, IN

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

K261563 — Freedom Total Knee System (E-Poly Tibial Liners)2026-08-07
K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.