U2 Bipolar Implant and 22mm Femoral Head— 510(k) K152439

Clearance details

Applicant

United Orthopedic Corporation

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2015-08-27

Decision date

2016-04-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsinchu, TW

• K253357 — b-ONE® Bipolar Head2026-04-13
• K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
• K231526 — CORAIL Cemented Femoral Stem2023-12-19
• K223441 — SpaceFlex Acetabular Cup2023-03-23
• K221794 — Vario-Cup System2022-07-20

• K253948 — Momentum Acetabular Cup System2026-09-02
• 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

Death

3

Injury

2,049

Total

2,052

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 →