U2 HIP SYSTEM— 510(k) K111546

Clearance details

Applicant

United Orthopedic Corp.

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2011-06-03

Decision date

2011-07-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsinchu, TW

• K253630 — Mpact 3D Metal Foam2026-08-28
• K254043 — TRIVANCE Hip Stem2026-08-04
• K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
• K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
• K251270 — Taperloc® Complete Hip Stem2026-05-19

• K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED2014-06-16
• K140075 — U2 FEMORAL COMPONENT, CR, POROUS COATED2014-06-13
• K132455 — U-MOTION II PS+ CUP2013-09-03
• K122185 — U-MOTION II ACETABULAR SYSTEM2013-02-22
• K122183 — AUGMENT AND SCREW, PSA TYPE2013-02-05

Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

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 →

• Z-1382-2013 — Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femoral head, ¿32mm, +0mm Femoral head, ¿32mm, +5mm Femoral head, ¿32mm, +10mm Femoral head, ¿36mm, -3mm Femoral head, ¿36mm, +0mm Femoral head, ¿36mm, +5mm Femoral head, ¿36mm, +10mm 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 K111546.