Cleared Traditional

TIBIAL INSERT (K963028) - FDA 510(k) Clearance

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

K963028 · Encore Orthopedics, Inc. · Orthopedic device
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Oct 1996
Decision
57d
Days
Class 2
Risk

K963028 is an FDA 510(k) clearance for the TIBIAL INSERT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on October 1, 1996 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K963028 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 05, 1996
Decision Date October 01, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 122d · This submission: 57d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K963028.
KONSTRUCT PATELLAR COMPONENT
K960856 · Biomet, Inc. · Nov 1996
DURACON POSTERIOR FEMORAL SPACER
K963242 · Howmedica Corp. · Nov 1996
P.F.C. CRUCIATE RETAING KNEE SYSTEM
K963117 · Johnson & Johnson Professionals, Inc. · Nov 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
KINEMATIC II REPLACEMENT TIBIAL INSERTS
K960976 · Howmedica Corp. · Aug 1996