Cleared Traditional

MODULAR HEAD BONE SCREW (K022952) - FDA 510(k) Clearance

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

K022952 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
88d
Days
Class 2
Risk

K022952 is an FDA 510(k) clearance for the MODULAR HEAD BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 88 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, Inc. devices

Submission Details

510(k) Number K022952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2002
Decision Date December 02, 2002
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K022952.
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · KARL STORZ Endoscopy-America, Inc. · Mar 2003
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · Howmedica Osteonics Corp. · Dec 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · Howmedica Osteonics Corp. · Oct 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · Smith & Nephew, Inc. · Oct 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · Arthrex, Inc. · Oct 2002