Summit 1570-21-014

by Depuy Orthopaedics, Inc.

Summit 1570-21-014 (157021014) is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K030122 on 5 Feb 2003 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295060390), 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

+2 more

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	Number10603295060390 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK030122	Date5 Feb 2003Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK023453	Date13 Nov 2002Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK013352	Date17 Dec 2001Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10603295060390
FDA 510(k) database 510(k) number K030122
FDA 510(k) database 510(k) number K023453
FDA 510(k) database 510(k) number K013352

Across registries

2 registries list this device

FDA 510(k) K030122 decided 5 Feb 2003 Active· +2 more in the status table
FDA GUDID UDI-DI 10603295060390 listed 24 Sep 2015 Listed

Timeline

4 dated events

17 Dec 2001 Cleared FDA 510(k) K013352
13 Nov 2002 Cleared FDA 510(k) K023453
5 Feb 2003 Cleared FDA 510(k) K030122
24 Sep 2015 Listed FDA GUDID 10603295060390

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Summit
Generic name: Press-fit hip femur prosthesis, modular
Model / Ref / Catalog: 1570-21-014, 157021014

Primary DI / UDI-DI: 10603295060390
510(k) Number: K013352
K023453
K030122
FDA product code: LWJ, JDI
GMDN term: Press-fit hip femur prosthesis, modular

Device class: Class II
Regulation number: 888.3360, 888.3350
GUDID distribution status: In Commercial Distribution

Other devices from Depuy Orthopaedics, Inc.

S-Rom

Class III
Global Advantage

Class III
Duraloc MARATHON

Class III
Pinnacle Porocoat

Class III

See all devices from Depuy Orthopaedics, Inc. →

Properties

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

Other properties (9, all answered No)