5450-32-500

by Depuy (Ireland)

5450-32-500 (545032500) is a Class II device made by Depuy (Ireland), cleared under FDA 510(k) K081163 on 14 May 2008 (4 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295174271), active as of 9 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

+4 more

Trust

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10603295174271 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK081163	Date14 May 2008Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK061144	Date8 Jun 2006Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK053002	Date22 Nov 2005Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK033382	Date5 Feb 2004Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK033563	Date5 Feb 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10603295174271
FDA 510(k) database 510(k) number K081163
FDA 510(k) database 510(k) number K061144
FDA 510(k) database 510(k) number K053002
FDA 510(k) database 510(k) number K033382
FDA 510(k) database 510(k) number K033563

Across registries

2 registries list this device

FDA 510(k) K081163 decided 14 May 2008 Active· +4 more in the status table
FDA GUDID UDI-DI 10603295174271 listed 24 Sep 2015 Listed

Recalls

1 recall · FDA

- Terminated Z-1246-2015 FDA Class II initiated 11 Feb 2015
One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.

Timeline

7 dated events

5 Feb 2004 Cleared FDA 510(k) K033382
5 Feb 2004 Cleared FDA 510(k) K033563
22 Nov 2005 Cleared FDA 510(k) K053002
8 Jun 2006 Cleared FDA 510(k) K061144
14 May 2008 Cleared FDA 510(k) K081163
11 Feb 2015 Recall initiated FDA recalls Z-1246-2015
24 Sep 2015 Listed FDA GUDID 10603295174271

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthopaedic cement, antimicrobial
Model / Ref / Catalog: 5450-32-500, 545032500

Primary DI / UDI-DI: 10603295174271
510(k) Number: K033382
K033563
K053002
K061144
K081163
FDA product code: LOD, MBB
GMDN term: Orthopaedic cement, antimicrobial

Device class: Class II
Regulation number: 888.3027
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Combination product
Lot / batch number
Expiration date

Other properties (8, all answered No)