UNITED U2 FEMORAL COMPONENT, PS, #7— 510(k) K120507

Name: FDA 510(k) clearance K120507
Creator: U.S. Food and Drug Administration
Published: 2012-05-04

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K120507 for UNITED U2 FEMORAL COMPONENT, PS, #7, Substantially Equivalent on 2012-05-04. 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: 2012-02-21
Decision date: 2012-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella2025-07-31
K242315 — Resolve Modular Revision Hip Stem2025-05-01

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 →

Recalls naming K120507

K-number listed on FDA's recall record

Z-1378-2013 — Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 Variety of hip and knee implants and instruments, multiple uses.Class II·Terminated·Orthopedic Alliance LLC·20130220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120507.

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