Cleared Traditional

K002070 - BIOLOK SCREW

K002070 is an FDA 510(k) clearance for BIOLOK SCREW, 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 49-day FDA review.

K002070 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
49d
Days
Class 2
Risk

K002070 is an FDA 510(k) clearance for the BIOLOK SCREW. 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 August 25, 2000 after a review of 49 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 Biocomposites, Ltd. devices

FDA 510(k) Submission Details - K002070

510(k) Number K002070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2000
Decision Date August 25, 2000
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 K002070.
SMITH & NEPHEW SUTURE ANCHOR
K003599 · Smith & Nephew, Inc. · Feb 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641 · Biocomposites, Ltd. · Feb 2001
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · Howmedica Osteonics Corp. · Sep 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271 · Synthes (Usa) · Aug 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · Stryker Endoscopy · Aug 2000
THE KALIX IMPLANT
K001231 · New Deal, S.A. · Jul 2000