Cleared Special

K071115 - MODIFICATION TO BILOK ST SCREW

K071115 is an FDA 510(k) clearance for MODIFICATION TO BILOK ST SCREW, manufactured by Biocomposites, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 27-day FDA review.

K071115 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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May 2007
Decision
27d
Days
Class 2
Risk

K071115 is an FDA 510(k) clearance for the MODIFICATION TO BILOK ST SCREW. 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 May 17, 2007 after a review of 27 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

FDA 510(k) Submission Details - K071115

510(k) Number K071115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2007
Decision Date May 17, 2007
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 985
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K071115.
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
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