UC-PLUS SOLUTION UNICONDYLAR KNEE— 510(k) K032052

Name: FDA 510(k) clearance K032052
Creator: U.S. Food and Drug Administration
Published: 2003-07-25

Substantially Equivalent

Plus Orthopedics

FDA 510(k) clearance K032052 for UC-PLUS SOLUTION UNICONDYLAR KNEE, Substantially Equivalent on 2003-07-25. Applicant: Plus Orthopedics. Device class: 2.

Clearance details

Applicant: Plus Orthopedics
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 2003-07-02
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRY

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K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
K190633 — NanoOrtho NanoKnee® System2019-12-20
K152631 — MPO Total Knee Systems MR Labeling2016-03-23
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

More clearances from Plus Orthopedics

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K032126 — PROMOS SHOULDER2004-01-08
K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM2003-12-18
K032709 — MODULAR PLUS HIP STEM2003-09-23
K032548 — IP-XS COMPRESSION NAIL SYSTEM2003-09-10
K032215 — VKS/TC-PLUS REVISION KNEE2003-08-08

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.