Cleared Traditional

ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM (K010525) - FDA 510(k) Clearance

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

K010525 · Arthrex, Inc. · Orthopedic device
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May 2001
Decision
90d
Days
Class 2
Risk

K010525 is an FDA 510(k) clearance for the ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 23, 2001 after a review of 90 days - within the typical 510(k) review window.

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: 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 Arthrex, Inc. devices

Submission Details

510(k) Number K010525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2001
Decision Date May 23, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 401
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010525.
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa) · Dec 2001
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · Aesculap, Inc. · Aug 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc. · Mar 2001
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