Cleared Special

K180960 - FIXIT / ComposiTCP Threaded Anchor System

K180960 is an FDA 510(k) clearance for FIXIT / ComposiTCP Threaded Anchor System, manufactured by S.B.M. Sas Sciences For Bio Materials. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 104-day FDA review.

K180960 · S.B.M. Sas Sciences For Bio Materials · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
104d
Days
Class 2
Risk

K180960 is an FDA 510(k) clearance for the FIXIT / ComposiTCP Threaded Anchor System. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by S.B.M. Sas Sciences For Bio Materials (Lourdes, FR). The FDA issued a Cleared decision on July 25, 2018 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K180960

510(k) Number K180960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2018
Decision Date July 25, 2018
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 220
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K180960.
Arthrex SwiveLock Anchors
K180768 · Arthrex, Inc. · Dec 2018
MICRORAPTOR Knotless Suture Anchor
K181746 · Smith and Nephew, Inc. · Sep 2018
GRYPHON® Anchors with DYNACORD™ Suture
K181809 · Medos International SARL · Aug 2018
CuffLink Implant System Biocomposite
K180763 · Conmed Corporation · Jul 2018
Knotless SutureTak Anchors
K180594 · Arthrex, Inc. · Jun 2018
MICRORAPTOR REGENESORB Suture Anchor
K180361 · Smith and Nephew, Inc. · May 2018
K180960 · FIXIT / ComposiTCP Threaded Anchor System
Download PDF FDA Summary S.B.M. Sas Sciences F…