Cleared Traditional

K001374 - PATIENT MATCHED COBALT ALLOY TROCHLEA R...

K001374 is the FDA 510(k) clearance for PATIENT MATCHED COBALT ALLOY TROCHLEA R... by Biomet Manufacturing, Inc.. It is a Class 2 Orthopedic device (product code KRR) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K001374 · Biomet Manufacturing, Inc. · Orthopedic device
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Jul 2000
Decision
87d
Days
Class 2
Risk

K001374 is an FDA 510(k) clearance for the PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 27, 2000 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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 Manufacturing, Inc. devices

Submission Details

510(k) Number K001374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2000
Decision Date July 27, 2000
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 21
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K001374.
AVON PATELLAR COMPONENT
K020841 · Howmedica Osteonics Corp. · Apr 2002
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · Howmedica Osteonics Corp. · Apr 2001
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
K002356 · Sulzer Orthopedics, Inc. · Oct 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · Biomet, Inc. · Jul 2000
PATELLOFEMORAL JOINT PROSTHESIS
K962190 · Intermedics Orthopedics · Oct 1996