Cleared Traditional

K912245 - AGC REVISION KNEE PROTHESIS

K912245 is an FDA 510(k) clearance for AGC REVISION KNEE PROTHESIS, 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 90-day FDA review.

K912245 · Biomet, Inc. · Orthopedic device
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Aug 1991
Decision
90d
Days
Class 2
Risk

K912245 is an FDA 510(k) clearance for the AGC REVISION KNEE PROTHESIS. 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 August 19, 1991 after a review of 90 days - within the typical 510(k) review window.

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. 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, Inc. devices

FDA 510(k) Submission Details - K912245

510(k) Number K912245 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 21, 1991
Decision Date August 19, 1991
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K912245.
KINEMAX PLUS TIBIAL INSERT
K913188 · Howmedica Corp. · Oct 1991
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
K912663 · Intermedics Orthopedics · Sep 1991
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
K910940 · Depuy, Inc. · Sep 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · Osteonics Corp. · Aug 1991
TOWNLEY TOTAL KNEE (TTK)
K904448 · Biopro, Inc. · Jul 1991
MG II POROUS COBAL T-CHROME FEMORAL COMPONENT
K911572 · Zimmer, Inc. · Jul 1991