Cleared Traditional

K011299 - SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR

K011299 is an FDA 510(k) clearance for SMITH AND NEPHEW 5.00MM ABSORBABLE POLY..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K011299 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
58d
Days
Class 2
Risk

K011299 is an FDA 510(k) clearance for the SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on June 27, 2001 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K011299

510(k) Number K011299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date June 27, 2001
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 212
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K011299.
BIOCUFF,C, MODELS 236018, 236028, 236036
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CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · Bionx Implants, Inc. · Sep 2001
ARTHREX BIO-POST AND WASHER
K011495 · Arthrex, Inc. · Aug 2001
SUPER REVO SUTURE ANCHOR
K003984 · Linvatec Corp. · Mar 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · Mitek Products · Feb 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · Synthes (Usa) · Feb 2001