Cleared Traditional

SELF-COUNTERSINKING BONE SCREW (K013534) - FDA 510(k) Clearance

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

K013534 · Biomet Orthopedics, Inc. · Orthopedic device
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Dec 2001
Decision
55d
Days
Class 2
Risk

K013534 is an FDA 510(k) clearance for the SELF-COUNTERSINKING BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 2001 after a review of 55 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 Biomet Orthopedics, Inc. devices

Submission Details

510(k) Number K013534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2001
Decision Date December 17, 2001
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K013534.
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · Biomet, Inc. · Jun 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · Arthrex, Inc. · Apr 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · Smith & Nephew, Inc. · Mar 2002
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc · Dec 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc. · Dec 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc. · Dec 2001