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Attune Knee System

by DePuy Ireland UC 157 variants

Ref 2546-00-456, 254603333, 254631485, 254603332, 2547-10-806, 2546-00-455

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a0051892 Basic UDI-DI Date23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295505051 UDI-DI Date14 Dec 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Attune Knee System EUDAMED
Attune GUDID
Attune Lps GUDID
Generic Name
Knee tibia prosthesis trial, reusable
Orthopaedic instrument surgical connector
Instrument tray, reusable
Orthopaedic prosthesis implantation positioning instrument, reusable
Bone-resection orthopaedic reamer, reusable
Knee femur prosthesis trial, reusable
Orthopaedic inorganic implant inserter/extractor, reusable
Orthopaedic broach
Surgical implant template, reusable
Surgical torque wrench, reusable
Device Name
Shim Inserter/Extractor
Impactor
Shim
Medial Stabilized Insert Trial
Model / Ref / Catalog
2546-00-456, 254603333, 254631485, 254603332, 2547-10-806, 2546-00-455, 2545-05-245, 2547-01-007, 2504-40-119, 2517-60-612, 2545-01-707, 2546-00-442, 2546-00-024, 2504-40-209, 2546-00-443, 2545-00-153, 2545-01-714, 2545-00-171, 2546-00-218, 2546-00-485, 2546-00-441, 2545-05-229, 2546-00-490, 2545-05-252, 2545-01-715, 2546-00-487, 2517-10-510, 2547-00-516, 2547-11-006, 2545-00-021, 2544-00-024, 2545-06-010, 2545-02-013, 2545-70-210, 2545-00-940, 2504-40-572, 2545-00-703, 2545-01-054, 2517-00-820, 2545-05-346, 2545-00-732, 2546-00-421, 2000-42-074, 2549-00-042, 2545-00-962, 2504-40-575, 2517-10-808, 2504-40-577, 2545-00-725, 2506-30-210, 254505245, 254701007, 250440119, 251760612, 254501707, 254600442, 254600024, 250440209, 254600443, 254500153, 254501714, 254500171, 254600218, 254600485, 254600441, 254505229, 254600490, 254505252, 254501715, 254600487, 251710510, 254700516, 254711006, 254500021, 254400024, 254506010, 254502013, 254570210, 254500940, 250440572, 254500703, 254501054, 254710806, 251700820, 254505346, 254500732, 254600421, 200042074, 254900042, 254500962, 250440575, 251710808, 250440577, 254500725, 250630210
Primary DI / UDI-DI
10603295505051, 10603295543725, 10603295543756, 10603295543718, 10603295539773, 10603295505044, 10603295481096, 10603295541264, 10603295442837, 10603295480181, 10603295423577, 10603295440178, 10603295440130, 10603295439851, 10603295440499, 10603295395348, 10603295442936, 10603295416029, 10603295439929, 10603295490388, 10603295440246, 10603295479604, 10603295490340, 10603295481027, 10603295452478, 10603295490401, 10603295481867, 10603295540915, 10603295539995, 10603295130383, 10603295395591, 10603295514381, 10603295489283, 10603295491620, 10603295135173, 10603295438120, 10603295133759, 10603295419778, 10603295475552, 10603295480013, 10603295134046, 10603295440345, 10603295383246, 10603295476092, 10603295135395, 10603295438083, 10603295481874, 10603295438380, 10603295133971, 10603295478577
Basic UDI-DI
0603295a0051892, 0603295a002228A, 0603295a002448L, 0603295a005889P
Direct Marketing DI
10603295505051
10603295543725
10603295543756
10603295543718
10603295539773
10603295505044
FDA Product Code
HWT, LXH, FSM, HTO, HWB, HTZ, LRY, HXC
EMDN Code
L0921, L091199
GMDN Term
Knee tibia prosthesis trial, reusable
Orthopaedic instrument surgical connector
Instrument tray, reusable
Orthopaedic prosthesis implantation positioning instrument, reusable
Bone-resection orthopaedic reamer, reusable
Knee femur prosthesis trial, reusable
Orthopaedic inorganic implant inserter/extractor, reusable
Orthopaedic broach
Surgical implant template, reusable
Surgical torque wrench, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
888.4800, 888.4540, 878.4800
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • CMR Substance YesEUDAMEDNoEUDAMED
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No