Cleared Traditional

K003629 - MTP RESESURFACING JOINT-SMALL/9301-01 (FDA 510(k) Clearance)

Also includes:
MEDIUM/9301-02 LARGE/9301-03

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

K003629 · Terray Corp. · Orthopedic device
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Feb 2001
Decision
90d
Days
Class 2
Risk

K003629 is an FDA 510(k) clearance for the MTP RESESURFACING JOINT-SMALL/9301-01. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Terray Corp. (Arnprior, CA). The FDA issued a Cleared decision on February 22, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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. Standard predicate reliance. 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 Terray Corp. devices

Submission Details

510(k) Number K003629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2000
Decision Date February 22, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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.