Cleared Traditional

K012872 - RESORBABLE SCREW ANCHOR

K012872 is the FDA 510(k) clearance for RESORBABLE SCREW ANCHOR by Arthrotek, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K012872 · Arthrotek, Inc. · Orthopedic device
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Nov 2001
Decision
85d
Days
Class 2
Risk

K012872 is an FDA 510(k) clearance for the RESORBABLE SCREW ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 85 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 K012872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2001
Decision Date November 20, 2001
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 568
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K012872.
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa) · Dec 2001
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
IN-FAST BONE SCREW SYSTEM
K011910 · American Medical Systems, Inc. · Jul 2001