Cleared Traditional

K960856 - KONSTRUCT PATELLAR COMPONENT

K960856 is an FDA 510(k) clearance for KONSTRUCT PATELLAR 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 271-day FDA review.

K960856 · Biomet, Inc. · Orthopedic device
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Nov 1996
Decision
271d
Days
Class 2
Risk

K960856 is an FDA 510(k) clearance for the KONSTRUCT PATELLAR 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 November 27, 1996 after a review of 271 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 - K960856

510(k) Number K960856 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 01, 1996
Decision Date November 27, 1996
Days to Decision 271 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
149d slower than avg
Panel avg: 122d · This submission: 271d
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 K960856.
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796 · Howmedica Corp. · Dec 1996
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
K962557 · Smith & Nephew Richards, Inc. · Dec 1996
CEMENT-ON FEMORAL STEM
K963709 · Biomet, Inc. · Dec 1996
DURACON POSTERIOR FEMORAL SPACER
K963242 · Howmedica Corp. · Nov 1996
P.F.C. CRUCIATE RETAING KNEE SYSTEM
K963117 · Johnson & Johnson Professionals, Inc. · Nov 1996
TIBIAL INSERT
K963028 · Encore Orthopedics, Inc. · Oct 1996