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Pinnacle 1219-36-062

by Depuy Orthopaedics, Inc.

Ref 1219-36-062Model PINNACLE, PINNACLE BANTAM Acetabular Liners - MARATHON UHMWPE

Pinnacle 1219-36-062 (121936062) is a device classified as Class III in the EU and Class II in the US made by Depuy Orthopaedics, Inc., registered in EUDAMED on 30 Jan 2026 (Basic UDI-DI 0603295a002758X) with CE/MDR certificate MDR 776549 valid until 4 Jun 2029, cleared under FDA 510(k) K010171 on 6 Apr 2001 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295014492), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

4 Jun 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K010171

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 776549 Date30 Jun 2026IssuedStatusActive expires 4 Jun 2029
United StatesGUDID listing GUDID Number10603295014492 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010171 Date6 Apr 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0603295a002758X registered 30 Jan 2026 Active· +1 more in the status table
  • FDA 510(k) K010171 decided 6 Apr 2001 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10603295014492 listed 24 Sep 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 776549 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    4 Jun 2029
    Reason
    Change approved

Timeline

7 dated events

  1. Cleared FDA 510(k) K983014
  2. Cleared FDA 510(k) K001534
  3. Cleared FDA 510(k) K010171
  4. Listed FDA GUDID 10603295014492
  5. Registered EUDAMED 0603295a002758X
  6. Certificate issued EUDAMED MDR 776549
  7. Certificate expires EUDAMED MDR 776549

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 · GUDID

Trade name
Pinnacle
Generic name
Non-constrained polyethylene acetabular liner
Device name
Acetabular Liners - MARATHON UHMWPE
Model / Ref / Catalog
1219-36-062, PINNACLE, PINNACLE BANTAM Acetabular Liners - MARATHON UHMWPE, 121936062
Primary DI / UDI-DI
10603295014492
Basic UDI-DI
0603295a002758X
FDA product code
LPH
EMDN code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3358
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K001534)

and 8 more cleared under K001534

Cleared under the same submission (K010171)

and 8 more cleared under K010171

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)