Summit

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: SUMMIT FDA UDI
Generic Name: Press-fit hip femur prosthesis, modular FDA UDI
Device Name: SUMMIT FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 8 160mm CEMENTLESS FDA UDI
Model / Reference: 1570-21-018 FDA UDI
Description: SUMMIT FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 8 160mm CEMENTLESS FDA UDI

Identifiers

Catalog Number: 157021018 FDA UDI
Primary DI / UDI-DI: 10603295060437 FDA UDI
510(k) Number: K013352 FDA UDI
K023453 FDA UDI
K030122 FDA UDI
FDA Product Code: JDI FDA UDI
LWJ FDA UDI
GMDN Term: Press-fit hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Press-fit hip femur prosthesis, modular

Summit by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Press-fit hip femur prosthesis, modular.

Perfecta — MicroPort Orthopedics Inc. · Class III
Alloclassic® Zweymüller® — Zimmer, Inc. · Class II
Wagner SL Revision® — Zimmer, Inc. · Class II
VerSys® — Zimmer, Inc. · Class II
Wagner Cone Prosthesis® — Zimmer, Inc. · Class II
Profemur — MicroPort Orthopedics Inc. · Class III
Alloclassic® Zweymüller® — Zimmer, Inc. · Class II
Profemur — MicroPort Orthopedics Inc. · Class III

Cleared under the same submission

K013352 also covers:

K023453 also covers:

K030122 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI 9951ee91-a28a-4ccb-bb32-2ee47b02f400 36 fields · synced Jun 6, 2026