U2 Total Knee System, XPE Tibial Insert, PS PLUS— 510(k) K210961

Name: FDA 510(k) clearance K210961
Creator: U.S. Food and Drug Administration
Published: 2021-04-21

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K210961 for U2 Total Knee System, XPE Tibial Insert, PS PLUS, Substantially Equivalent on 2021-04-21. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2021-03-31
Decision date: 2021-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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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

More clearances from United Orthopedic Corporation

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K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type)2025-09-25
K252303 — Stem Extension Line (USTAR II System)2025-08-22
K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella2025-07-31
K242315 — Resolve Modular Revision Hip Stem2025-05-01
K243466 — Conformity Stem Extension Line, #02025-01-06

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.