Cleared Traditional

K935726 - EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT

K935726 is an FDA 510(k) clearance for EXACTECH POROUS COATED CRUCIATE RETAINE..., manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K935726 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K935726

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.

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 895
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K935726.
PCA MODULAR PRIMARY/REVISION PATELLA
K940713 · Howmedica Corp. · Nov 1994
FOUNDATION POSTERIOR STABILIZED KNEE
K933539 · Encore Orthopedics, Inc. · Nov 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · Exactech, Inc. · Oct 1994
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
K926334 · Orthomet, Inc. · Oct 1994
AXIOM TOTAL KNEE SYSTEM
K932677 · Orthomet, Inc. · Oct 1994
NUFFIELD TOTAL KNEE
K931960 · Turnkey Intergration USA, Inc. · Oct 1994