Performa

FDA UDI

Class II (US FDA UDI)

by Implants International Ltd

Identity

Trade Name: Performa FDA UDI
Generic Name: Uncoated femoral stem prosthesis, modular FDA UDI
Device Name: Collarless Hip Stem for cemented applications - Size 4 (165 x 12mm) LONG (12/14 Taper) FDA UDI
Model / Reference: Collarless Hip Stem - Size 4 (165 x 12mm) LONG FDA UDI
Description: Collarless Hip Stem for cemented applications - Size 4 (165 x 12mm) LONG (12/14 Taper) FDA UDI

Identifiers

Catalog Number: HS1370 FDA UDI
Primary DI / UDI-DI: 05051693301061 FDA UDI
510(k) Number: K923898 FDA UDI
FDA Product Code: JDI FDA UDI
GMDN Term: Uncoated femoral stem prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 65 Millimeter FDA UDI

Category: Uncoated femoral stem prosthesis, modular

Performa by Implants International Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated femoral stem prosthesis, modular.

Profemur — MicroPort Orthopedics Inc. · Class III
Perfecta — MicroPort Orthopedics Inc. · Class II
GUARDIAN® — MicroPort Orthopedics Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Perfecta — MicroPort Orthopedics Inc. · Class III
GUARDIAN® — MicroPort Orthopedics Inc. · Class II

Cleared under the same submission

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: Implants International Ltd

Sources (1)

FDA UDI 69ea3b37-899d-4db5-8fe9-21bcd4429691 38 fields · synced Jun 8, 2026