Cleared Traditional

K932776 - CRUCIATE RETAINING CEMENTED TIBIAL COMP...

K932776 is the FDA 510(k) clearance for CRUCIATE RETAINING CEMENTED TIBIAL COMP... by Exactech, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 499-day FDA review.

K932776 · Exactech, Inc. · Orthopedic device
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Oct 1994
Decision
499d
Days
Class 2
Risk

K932776 is an FDA 510(k) clearance for the CRUCIATE RETAINING CEMENTED 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 October 20, 1994 after a review of 499 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 K932776 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 08, 1993
Decision Date October 20, 1994
Days to Decision 499 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
377d slower than avg
Panel avg: 122d · This submission: 499d
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 787
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