Cleared Traditional

K021351 - BIOSTEON CROSS PIN

K021351 is an FDA 510(k) clearance for BIOSTEON CROSS PIN, manufactured by Biocomposites, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K021351 · Biocomposites, Ltd. · Orthopedic device
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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

FDA 510(k) Submission Details - K021351

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K021351.
AAP CANNULATED SCREWS
K021233 · Aap Implantate AG · Dec 2002
MODULAR HEAD BONE SCREW
K022952 · Biomet, Inc. · Dec 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · Osteomed Corp. · Oct 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