Cleared Traditional

K003599 - SMITH & NEPHEW SUTURE ANCHOR

K003599 is the FDA 510(k) clearance for SMITH & NEPHEW SUTURE ANCHOR by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K003599 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
86d
Days
Class 2
Risk

K003599 is an FDA 510(k) clearance for the SMITH & NEPHEW SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

Submission Details

510(k) Number K003599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2000
Decision Date February 15, 2001
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K003599.
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
K003816 · Arthrex, Inc. · Mar 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · Smith & Nephew, Inc. · Mar 2001
SYNTHES HAMSTRING LOOP
K003700 · Synthes (Usa) · Feb 2001
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · Howmedica Osteonics Corp. · Sep 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271 · Synthes (Usa) · Aug 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · Stryker Endoscopy · Aug 2000