Cleared Traditional

K961021 - KIRSCHNER KNEE MODIFIED

K961021 is an FDA 510(k) clearance for KIRSCHNER KNEE MODIFIED, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K961021 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961021

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.

JWH Device Classification - Class 2, Special Controls

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 894
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K961021.
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758 · Howmedica Corp. · May 1997
NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498 · Intermedics Orthopedics · Apr 1997
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
K970031 · Encore Orthopedics, Inc. · Apr 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · Howmedica Corp. · Feb 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148 · Zimmer, Inc. · Feb 1997
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
K963255 · Smith & Nephew, Inc., Orthopaedic Div. · Jan 1997