Cleared Traditional

K960976 - KINEMATIC II REPLACEMENT TIBIAL INSERTS

K960976 is an FDA 510(k) clearance for KINEMATIC II REPLACEMENT TIBIAL INSERTS, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K960976 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
149d
Days
Class 2
Risk

K960976 is an FDA 510(k) clearance for the KINEMATIC II REPLACEMENT TIBIAL INSERTS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 149 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K960976

510(k) Number K960976 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 11, 1996
Decision Date August 07, 1996
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K960976.
TIBIAL INSERT
K963028 · Encore Orthopedics, Inc. · Oct 1996
NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS
K962196 · Zimmer, Inc. · Aug 1996
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
K962152 · Osteonics Corp. · Aug 1996
GENESIS II CONSTRAINED SYSTEM
K962137 · Smith & Nephew Richards, Inc. · Aug 1996
P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
K961685 · Johnson & Johnson Professionals, Inc. · Jul 1996
DURACON ALL POLYETHYLENE PATELLA II
K961483 · Howmedica Corp. · Jul 1996