Cleared Traditional

KIRSCHNER KNEE MODIFIED (K961021) - FDA 510(k) Clearance

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

K961021 · Biomet, Inc. · Orthopedic device
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Mar 1997
Decision
368d
Days
Class 2
Risk

K961021 is an FDA 510(k) clearance for the KIRSCHNER KNEE MODIFIED. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 17, 1997 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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. Elevated predicate reliance profile. 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, Inc. devices

Submission Details

510(k) Number K961021 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 14, 1996
Decision Date March 17, 1997
Days to Decision 368 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 122d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K961021.
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550 · Howmedica Corp. · Jul 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K965173 · Howmedica Corp. · Jun 1997
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758 · Howmedica Corp. · May 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · Howmedica Corp. · Feb 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148 · Zimmer, Inc. · Feb 1997
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796 · Howmedica Corp. · Dec 1996