00-5850-030-38

by Zimmer, Inc.

00-5850-030-38 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K183136 on 30 Jan 2019 (1 earlier submission) and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00889024195806), active as of 23 Oct 2026. 2 FDA recalls are 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

2 closed

Documents

+1 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK183136	Date30 Jan 2019Decided	StatusActive
United States	GUDID listing	Number00889024195806 UDI-DI	Date17 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK101296	Date30 Jul 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024195806
FDA 510(k) database 510(k) number K183136
FDA 510(k) database 510(k) number K101296

Across registries

2 registries list this device

FDA 510(k) K183136 decided 30 Jan 2019 Active· +1 more in the status table
FDA GUDID UDI-DI 00889024195806 listed 17 Sep 2015 Listed

Recalls

2 recalls · FDA

- Terminated Z-1381-2018 FDA Class II initiated 29 Mar 2018
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
- Terminated Z-1219-2015 FDA Class II initiated 5 Feb 2015
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

Timeline

5 dated events

30 Jul 2010 Cleared FDA 510(k) K101296
5 Feb 2015 Recall initiated FDA recalls Z-1219-2015
17 Sep 2015 Listed FDA GUDID 00889024195806
29 Mar 2018 Recall initiated FDA recalls Z-1381-2018
30 Jan 2019 Cleared FDA 510(k) K183136

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Revision uncoated hip femur prosthesis
Model / Ref / Catalog: 00-5850-030-38

Primary DI / UDI-DI: 00889024195806
510(k) Number: K101296
K183136
FDA product code: LZO, JDI
GMDN term: Revision uncoated hip femur prosthesis

Device class: Class II
Regulation number: 888.3353, 888.3350
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Revision uncoated hip femur prosthesis.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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

Other properties (9, all answered No)