Cleared Traditional

K934166 - NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION

K934166 is an FDA 510(k) clearance for NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE P..., manufactured by Corin Orthopedic Products. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K934166 · Corin Orthopedic Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
376d
Days
Class 2
Risk

K934166 is an FDA 510(k) clearance for the NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Corin Orthopedic Products (Tampa, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corin Orthopedic Products devices

FDA 510(k) Submission Details - K934166

510(k) Number K934166 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 27, 1993
Decision Date September 07, 1994
Days to Decision 376 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 122d · This submission: 376d
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 911
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K934166.
S-ROM NOILES CRUCIATE RETAINING KNEE
K936037 · Joint Medical Products Corp. · Oct 1994
CONSENSUS KNEE SYSTEM - PRIMARY KNEE
K932837 · U.S. Medical Products, Inc. · Sep 1994
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
K932210 · Dow Corning Wright · Sep 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · Exactech, Inc. · Sep 1994
ORTHOLOC ADVANTIM
K933290 · Wrightmedicaltechnologyinc · Sep 1994
ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE
K934620 · Wrightmedicaltechnologyinc · Sep 1994