Cleared Traditional

K981996 - TITANIUM FEMORAL COMPONENT

K981996 is an FDA 510(k) clearance for TITANIUM FEMORAL COMPONENT, 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 275-day FDA review.

K981996 · Biomet, Inc. · Orthopedic device
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Mar 1999
Decision
275d
Days
Class 2
Risk

K981996 is an FDA 510(k) clearance for the TITANIUM FEMORAL COMPONENT. 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 10, 1999 after a review of 275 days - an extended review cycle.

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 - K981996

510(k) Number K981996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date March 10, 1999
Days to Decision 275 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
153d slower than avg
Panel avg: 122d · This submission: 275d
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 893
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K981996.
OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
K991461 · Howmedica Osteonics Corp. · May 1999
GAS PLASMA STERILIZATION
K972774 · Zimmer, Inc. · May 1999
IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
K983835 · Implex Corp. · Mar 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K984623 · Biomet, Inc. · Mar 1999
ADVANCED REVISION PRODUCT LINE EXTENSION
K990030 · Wrightmedicaltechnologyinc · Feb 1999
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT
K984291 · Implex Corp. · Feb 1999