Cleared Traditional

K042460 - TI - SCREW ANCHOR SP (FDA 510(k) Clearance)

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

K042460 · Arthrotek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
49d
Days
Class 2
Risk

K042460 is an FDA 510(k) clearance for the TI - SCREW ANCHOR SP. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 29, 2004 after a review of 49 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 Arthrotek, Inc. devices

Submission Details

510(k) Number K042460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2004
Decision Date October 29, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 590
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K042460.
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · Tigon Medical · Apr 2026
Arthrex FiberTak Suture Anchor
K260561 · Arthrex, Inc. · Mar 2026
Grappler Suture Anchor PCFD Tether System
K253886 · Paragon 28, Inc. · Mar 2026
SINEFIX
K254176 · BAAT Medical Products B.V. · Mar 2026
Trax EX Anchor
K251750 · Trax Surgical, Inc. · Mar 2026