Cleared Traditional

K994161 - SYNTHES BIORESORBABLE SUTURE ANCHOR

K994161 is an FDA 510(k) clearance for SYNTHES BIORESORBABLE SUTURE ANCHOR, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K994161 · Synthes (Usa) · Orthopedic device
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Jul 2000
Decision
232d
Days
Class 2
Risk

K994161 is an FDA 510(k) clearance for the SYNTHES BIORESORBABLE SUTURE ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 28, 2000 after a review of 232 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K994161

510(k) Number K994161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date July 28, 2000
Days to Decision 232 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 122d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 211
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K994161.
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K990340 · Arthrex, Inc. · Jan 2000
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
K990987 · Arthrex, Inc. · Jan 2000