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ComposiTCP Threaded Anchor System

by S.B.M. Sas Sciences For Bio Materials

510(k) K180960

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180960↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK180960 Date25 Jul 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
FIXIT / ComposiTCP Threaded Anchor System
510(k) Number
FDA Product Code
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ComposiTCP Threaded Anchor System is a biodegradable soft tissue fixation device designed for orthopedic applications. It functions as a threaded anchor intended to secure soft tissue to bone, providing stable fixation through its mechanical properties and biocompatible materials.

This system is supplied sterile and intended for single-use in surgical settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The anchors are available in various sizes and configurations, as referenced in the product codes, and must be stored according to manufacturer instructions to maintain sterility and integrity.

Other devices from Sbm Sciences For Bio Materials

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the ComposiTCP Threaded Anchor System intended to support?

    The ComposiTCP Threaded Anchor System is designed specifically for orthopedic applications where soft tissue needs to be securely attached to bone. It is particularly useful in procedures requiring stable fixation, such as ligament or tendon repairs, where biodegradable anchors can provide temporary support that gradually integrates with the body.

  • Are the ComposiTCP anchors reusable or single-use, and how should they be stored to maintain integrity?

    The ComposiTCP Threaded Anchor System is explicitly intended for single-use only in surgical settings. To preserve sterility and structural integrity, storage must follow the manufacturer’s instructions, which likely include keeping the packaging sealed and protected from contamination until use.

  • What sizes or configurations are available for the ComposiTCP anchors, and how can I verify compatibility for my procedure?

    The system comes in multiple sizes and configurations, as referenced by the listed product codes (e.g., MAI, 1221051, etc.). These variations cater to different anatomical requirements. For precise compatibility, consult the manufacturer’s catalog or technical documentation, which details the specific dimensions and applications for each variant.

  • How is the sterility of the ComposiTCP anchors ensured, and what precautions should be taken during handling?

    The anchors are supplied sterile as part of the system’s design. To maintain sterility, avoid opening the packaging until immediate use and adhere to standard sterile field protocols during surgery. The manufacturer’s instructions should outline any additional handling precautions to prevent contamination.

  • What regulatory pathways have been followed for the ComposiTCP Threaded Anchor System, and how does this affect its use?

    The device has received FDA 510(k) clearance and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. This means it meets the necessary safety and performance criteria for marketing and use in approved regions. Always verify local regulations and compliance requirements before implementation.