Cleared Traditional

OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT (K011138) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011138 · Biomet, Inc. · Orthopedic device
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Jul 2001
Decision
88d
Days
Class 2
Risk

K011138 is an FDA 510(k) clearance for the OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 10, 2001 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K011138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date July 10, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 50
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K011138.
FIXED BEARING UNI COMPONENT
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ADVANCE UNICONDYLAR KNEE SYSTEM
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ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · Wrightmedicaltechnologyinc · Nov 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · Biomet, Inc. · Jun 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · Biomet, Inc. · Jun 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
K010810 · DePuy Orthopaedics, Inc. · Apr 2001