Cleared Traditional

K933610 - EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS (FDA 510(k) Clearance)

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

K933610 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
539d
Days
Class 2
Risk

K933610 is an FDA 510(k) clearance for the EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS. 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 January 17, 1995 after a review of 539 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Exactech, Inc. devices

Submission Details

510(k) Number K933610 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 27, 1993
Decision Date January 17, 1995
Days to Decision 539 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
417d slower than avg
Panel avg: 122d · This submission: 539d
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 910
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K933610.
NovoKnee (SteriKnee)
K261032 · NovoSource · Apr 2026
Materialise TKA Guide System
K253793 · Materialise NV · Jan 2026
EMPOWR Knee
K252974 · Encore Medical, L.P. · Dec 2025
ATTUNE™ Total Knee System
K253197 · Depuy Ireland UC · Nov 2025
Freedom Infinia™ Total Knee System
K253314 · Maxx Orthopedics, Inc. · Oct 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · Maxx Orthopedics, Inc. · Oct 2025