Cleared Special

K081428 - MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR

K081428 is the FDA 510(k) clearance for MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR by Biocomposites, Ltd.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 30-day FDA review.

K081428 · Biocomposites, Ltd. · Orthopedic device
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Jun 2008
Decision
30d
Days
Class 2
Risk

K081428 is an FDA 510(k) clearance for the MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on June 20, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biocomposites, Ltd. devices

Submission Details

510(k) Number K081428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2008
Decision Date June 20, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 561
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081428.
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
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SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · Synthes (Usa) · May 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · Synthes (Usa) · Apr 2008
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K080850 · Wrightmedicaltechnologyinc · Apr 2008