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Femoral Drilling Socket D29

by Episurf Operations AB

Ref 13117, 13117N, 13115, 53115, 43115N, 33129, 13120, 53120N, 53125N, 53117, 13112, 13115N, 43115, 13120N, 13112N

Femoral Drilling Socket D29 (33129PF) is a device classified as Class IIa in the EU and Class II in the US made by Episurf Operations AB, registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI B-+EPIS131170), cleared under FDA 510(k) K221048 on 23 Dec 2022 and listed in FDA GUDID since 24 Jul 2023 (UDI-DI +EPIS131170), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221048

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EPIS131170 Basic UDI-DI Date29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPIS131170 UDI-DI Date24 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221048 Date23 Dec 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+EPIS131170 registered 29 Apr 2026 Active
  • FDA 510(k) K221048 decided 23 Dec 2022 Active
  • FDA GUDID UDI-DI +EPIS131170 listed 24 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K221048
  2. Listed FDA GUDID +EPIS131170
  3. Registered EUDAMED B-+EPIS131170

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  • Withdrawn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
Drilling Socket EUDAMED
Femoral Drilling Socket GUDID
Generic name
Joint prosthesis implantation kit, single-use
Model / Ref / Catalog
13117 EUDAMED
13117N EUDAMED
13115 EUDAMED
53115 EUDAMED
43115N EUDAMED
33129 EUDAMED
13120 EUDAMED
53120N EUDAMED
53125N EUDAMED
53117 EUDAMED
13112 EUDAMED
13115N EUDAMED
43115 EUDAMED
13120N EUDAMED
13112N EUDAMED
D29 GUDID
33129PF GUDID
Primary DI / UDI-DI
+EPIS131170 EUDAMED
+EPIS13117N0 EUDAMED
+EPIS131150 EUDAMED
+EPIS531150 EUDAMED
+EPIS43115N0 EUDAMED
+EPIS331290 EUDAMED
+EPIS131200 EUDAMED
+EPIS53120N0 EUDAMED
+EPIS53125N0 EUDAMED
+EPIS531170 EUDAMED
+EPIS131120 EUDAMED
+EPIS13115N0 EUDAMED
+EPIS431150 EUDAMED
+EPIS13120N0 EUDAMED
+EPIS13112N0 EUDAMED
EPIS33129PF0 GUDID
Basic UDI-DI
B-+EPIS131170, B-+EPIS13117N0, B-+EPIS131150, B-+EPIS531150, B-+EPIS43115N0, B-+EPIS331290, B-+EPIS131200, B-+EPIS53120N0, B-+EPIS53125N0, B-+EPIS531170, B-+EPIS131120, B-+EPIS13115N0, B-+EPIS431150, B-+EPIS13120N0, B-+EPIS13112N0
510(k) Number
FDA product code
KRR
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Joint prosthesis implantation kit, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3540
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
Poland
Denmark
Germany
Norway
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 5 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
13117
13117N
13115
53115
43115N
33129
13120
53120N
53125N
53117
13112
13115N
43115
13120N
13112N
GUDID
D29
Primary DI / UDI-DIEUDAMED
+EPIS131170
+EPIS13117N0
+EPIS131150
+EPIS531150
+EPIS43115N0
+EPIS331290
+EPIS131200
+EPIS53120N0
+EPIS53125N0
+EPIS531170
+EPIS131120
+EPIS13115N0
+EPIS431150
+EPIS13120N0
+EPIS13112N0
GUDID
EPIS33129PF0
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
Yes
No
GUDID
Yes
Sterilise before useEUDAMED
No
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EPIS131170, +EPIS13117N0, +EPIS131150, +EPIS531150, +EPIS43115N0; FDA GUDID lists EPIS33129PF0), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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: Joint prosthesis implantation kit, single-use

Cleared under the same submission (K221048)

and 8 more cleared under K221048

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Episurf Operations AB

See all devices from Episurf Operations AB →

Properties

  • Supplied sterile YesEUDAMEDGUDIDNoEUDAMED
  • Sterilise before use NoEUDAMEDGUDIDYesEUDAMED
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)