U2 ACETABULAR CUP, PLASMA SPRAY— 510(k) K121777

Name: FDA 510(k) clearance K121777
Creator: U.S. Food and Drug Administration
Published: 2012-07-18

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K121777 for U2 ACETABULAR CUP, PLASMA SPRAY, Substantially Equivalent on 2012-07-18. Applicant: United Orthopedic Corp.. Device class: 2.

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2012-06-18
Decision date: 2012-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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More clearances from United Orthopedic Corp.

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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
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Adverse events under product code LPH

product code LPH

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 →

Recalls naming K121777

K-number listed on FDA's recall record

Z-1381-2013 — U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads porous coated, ¿54mm U2 Acetabular cup, Ti beads porous coated, ¿56mm U2 Acetabular cup, Ti beads porous coated, ¿58mm U2 Acetabular cup, Ti beads porous coated, ¿60mm U2 Acetabular cup, Ti beads porous coated, ¿62mm U2 Acetabular cup liner assembly, 10¿hooded,44mm U2 Acetabular cup liner assembly, 10¿hooded,46mm U2 Acetabular cup liner assembly, 10¿hooded,48mm U2 Acetabular cup liner assembly, 10¿hooded,50mm U2 Acetabular cup liner assembly, 10¿hooded,52mm U2 Acetabular cup liner assembly, 10¿hooded,54mm U2 Acetabular cup liner assembly, 10¿hooded,56mm U2 Acetabular cup liner assembly, 10¿hooded,58mm U2 Acetabular cup liner assembly, 10¿hooded,60mm U2 Acetabular cup liner assembly, 10¿hooded,62mm 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 K121777.

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