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ComposiTCP 60 flat head

by S.B.M 4 variants

Ref 905264Model Absorbable interference screw, 60% TCP + 40% PLDLLA, Fully threaded

ComposiTCP 60 flat head (905264) is a device classified as Class III in the EU and Class II in the US made by S.B.M, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI B-03760154006743), cleared under FDA 510(k) K122228 on 3 Oct 2012 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2015 (UDI-DI 03760154006743), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122228

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154006743 Basic UDI-DI 03760154006743UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154006743 UDI-DI Date23 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK122228 Date3 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154006743 registered 8 Oct 2026 Active
  • FDA 510(k) K122228 decided 3 Oct 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03760154006743 listed 23 Sep 2015 Listed

Recalls

1 recall · FDA

    • Completed Z-1361-2022 FDA Class II initiated 7 Oct 2021 on shared 510(k) K070507

    Mislabeled product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K070507
  2. Cleared FDA 510(k) K122228
  3. Listed FDA GUDID 03760154006743
  4. Recall initiated FDA recalls Z-1361-2022
  5. Registered EUDAMED B-03760154006743

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ComposiTCP
Generic name
Bioabsorbable orthopaedic bone screw
Model / Ref / Catalog
Absorbable interference screw, 60% TCP + 40% PLDLLA, Fully threaded, 905264, ComposiTCP 60 flat head
Primary DI / UDI-DI
03760154006743
Basic UDI-DI
B-03760154006743
FDA product code
MAI
EMDN code
P09120605 Interference screws
GMDN term
Bioabsorbable orthopaedic bone screw
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 35 Millimeter
Outer Diameter — 11 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Absorbable interference screw, 60% TCP + 40% PLDLLA, Fully threaded
905264
GUDID
ComposiTCP 60 flat head
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bioabsorbable orthopaedic bone screw

Cleared under the same submission (K070507)

and 5 more cleared under K070507

Cleared under the same submission (K122228)

and 8 more cleared under K122228

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)