Cleared Traditional

EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT (K935726) - FDA 510(k) Clearance

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

K935726 · Exactech, Inc. · Orthopedic device
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Oct 1994
Decision
323d
Days
Class 2
Risk

K935726 is an FDA 510(k) clearance for the EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 323 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 Exactech, Inc. devices

Submission Details

510(k) Number K935726 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 01, 1993
Decision Date October 20, 1994
Days to Decision 323 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
201d slower than avg
Panel avg: 122d · This submission: 323d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K935726.
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128 · Osteonics Corp. · Dec 1994
PCA MODULAR PRIMARY/REVISION PATELLA
K940713 · Howmedica Corp. · Nov 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · Exactech, Inc. · Oct 1994
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT
K940235 · Wrightmedicaltechnologyinc · Oct 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · Exactech, Inc. · Sep 1994
ORTHOLOC ADVANTIM
K933290 · Wrightmedicaltechnologyinc · Sep 1994