Cleared Traditional

K061681 - REPICCI II METAL BACK INLAY UNICOMPARTM...

K061681 is the FDA 510(k) clearance for REPICCI II METAL BACK INLAY UNICOMPARTM... by Biomet Manufacturing Corp. It is a Class 2 Orthopedic device (product code HRY) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K061681 · Biomet Manufacturing Corp · Orthopedic device
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Oct 2006
Decision
126d
Days
Class 2
Risk

K061681 is an FDA 510(k) clearance for the REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 19, 2006 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K061681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date October 19, 2006
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K061681.
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K063515 · Biomet Manufacturing, Inc. · Feb 2007
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · Biomet Manufacturing, Inc. · Jan 2006
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K050764 · Corin USA · Aug 2005
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K042093 · Biomet, Inc. · Nov 2004