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FIXIT Threaded anchor system

by S.B.M 3 variants

Ref EPA0047CLAModel anchor + 2 sutures + screwdriver

FIXIT Threaded anchor system (EPA0047CLA) 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 6 Oct 2026 (Basic UDI-DI B-03760154008846), cleared under FDA 510(k) K170868 on 30 Nov 2017 and listed in FDA GUDID since 6 Dec 2017 (UDI-DI 03760154008846), active as of 25 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 found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154008846 Basic UDI-DI 03760154008846UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154008846 UDI-DI Date6 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170868 Date30 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154008846 registered 6 Oct 2026 Active
  • FDA 510(k) K170868 decided 30 Nov 2017 Active
  • FDA GUDID UDI-DI 03760154008846 listed 6 Dec 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170868
  2. Listed FDA GUDID 03760154008846
  3. Registered EUDAMED B-03760154008846

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  • Withdrawn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
Fixit
Generic name
Tendon/ligament bone anchor, bioabsorbable
Device name
implant for rotator cuff repair
Model / Ref / Catalog
anchor + 2 sutures + screwdriver, EPA0047CLA, FIXIT Threaded anchor system
Primary DI / UDI-DI
03760154008846
Basic UDI-DI
B-03760154008846
510(k) Number
FDA product code
MAI
EMDN code
P090199 Shoulder prostheses - other
GMDN term
Tendon/ligament bone anchor, bioabsorbable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Outer Diameter — 4.7 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
anchor + 2 sutures + screwdriver
EPA0047CLA
GUDID
FIXIT Threaded anchor system
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: Tendon/ligament bone anchor, bioabsorbable

Cleared under the same submission (K170868)

and 6 more cleared under K170868

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES - OTHER.

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)