CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE— 510(k) K945589

Name: FDA 510(k) clearance K945589
Creator: U.S. Food and Drug Administration
Published: 1995-05-31

Substantially Equivalent

U.S. Medical Products, Inc.

FDA 510(k) clearance K945589 for CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE, Substantially Equivalent on 1995-05-31. Applicant: U.S. Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: U.S. Medical Products, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1994-11-14
Decision date: 1995-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

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K953443 — CONSENSUS PCL SUBSITUTING TIBIAL INSERT1996-04-26
K952943 — CONSENSUS ALL POLY TIBIA1996-04-01
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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 →

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