00-5850-046-05

by Zimmer, Inc.

00-5850-046-05 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K110940 on 1 Jul 2011 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00889024196018), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024196018 UDI-DI	Date17 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK110940	Date1 Jul 2011Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024196018
FDA 510(k) database 510(k) number K110940

Across registries

2 registries list this device

FDA 510(k) K110940 decided 1 Jul 2011 Active
FDA GUDID UDI-DI 00889024196018 listed 17 Sep 2015 Listed

Timeline

2 dated events

1 Jul 2011 Cleared FDA 510(k) K110940
17 Sep 2015 Listed FDA GUDID 00889024196018

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Knee femur stem prosthesis
Model / Ref / Catalog: 00-5850-046-05

Primary DI / UDI-DI: 00889024196018
510(k) Number: K110940
FDA product code: KRO, KWY, KWL, KWZ, LWJ, LPH, JDI, LZO
GMDN term: Knee femur stem prosthesis

Device class: Class II
Regulation number: 888.3510, 888.3390, 888.3360, 888.3310, 888.3358, 888.3350, 888.3353
GUDID distribution status: In Commercial Distribution

Size: Length — 50 Millimeter

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)