Cleared Traditional

K953443 - CONSENSUS PCL SUBSITUTING TIBIAL INSERT

K953443 is an FDA 510(k) clearance for CONSENSUS PCL SUBSITUTING TIBIAL INSERT, manufactured by U.S. Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K953443 · U.S. Medical Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
284d
Days
Class 2
Risk

K953443 is an FDA 510(k) clearance for the CONSENSUS PCL SUBSITUTING TIBIAL INSERT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by U.S. Medical Products, Inc. (Austin, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 284 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 U.S. Medical Products, Inc. devices

FDA 510(k) Submission Details - K953443

510(k) Number K953443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date April 26, 1996
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K953443.
DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
K961379 · Depuy, Inc. · Jun 1996
CONSENSUS POSTERIOR STABILIZED KNEE
K954818 · U.S. Medical Products, Inc. · May 1996
NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
K934695 · Intermedics Orthopedics · May 1996
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
K960279 · Zimmer, Inc. · Apr 1996
APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
K960535 · Intermedics Orthopedics · Apr 1996
CONSENSUS ALL POLY TIBIA
K952943 · U.S. Medical Products, Inc. · Apr 1996