Cleared Abbreviated

K032901 - STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM

K032901 is the FDA 510(k) clearance for STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM by Stryker Endoscopy. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K032901 · Stryker Endoscopy · General & Plastic Surgery device
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Dec 2003
Decision
76d
Days
Class 2
Risk

K032901 is an FDA 510(k) clearance for the STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on December 2, 2003 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Stryker Endoscopy devices

Submission Details

510(k) Number K032901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date December 02, 2003
Days to Decision 76 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 94
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