Cleared Traditional

BIOSTEON CROSS PIN (K021351) - FDA 510(k) Clearance

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

K021351 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
171d
Days
Class 2
Risk

K021351 is an FDA 510(k) clearance for the BIOSTEON CROSS PIN. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on October 17, 2002 after a review of 171 days - an extended review 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: 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 Biocomposites, Ltd. devices

Submission Details

510(k) Number K021351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2002
Decision Date October 17, 2002
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K021351.
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
MODULAR HEAD BONE SCREW
K022952 · Biomet, Inc. · 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