Kyocera Medical Technologies, Inc.

FDA UDI

Class II (US FDA UDI)

by Kyocera Medical Technologies, Inc.

Identity

Trade Name: Kyocera Medical Technologies, Inc. FDA UDI
Generic Name: Coated femoral stem prosthesis, modular FDA UDI
Device Name: Tapered Femoral Stem, Lateral Offset, 12.75mm FDA UDI
Model / Reference: A 400 FDA UDI
Description: Tapered Femoral Stem, Lateral Offset, 12.75mm FDA UDI

Identifiers

Catalog Number: 1401-622-127 FDA UDI
Primary DI / UDI-DI: 00841523102976 FDA UDI
510(k) Number: K112897 FDA UDI
FDA Product Code: OQI FDA UDI
OQG FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Coated femoral stem prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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Single Use

Yes

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Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Coated femoral stem prosthesis, modular

Kyocera Medical Technologies, Inc.'s Coated Femoral Stem Prosthesis, Modular is a high-quality implantable device designed to replace the proximal femoral neck in total hip arthroplasty (THA). Made of metal-coated segments designed for improved fixation and stability through bone ingrowth, this modular prosthesis offers a versatile solution for surgeons. With its advanced coating materials and secure attachment, it provides reliable performance and minimal complications.

Similar devices

Also classified as Coated femoral stem prosthesis, modular.

MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Alteon — Exactech, Inc. · Class II
ANTHOLOGY — Smith & Nephew, Inc. · Class III
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II

Cleared under the same submission

K112897 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: Kyocera Medical Technologies, Inc.

Sources (1)

FDA UDI 3aaa46c2-f6da-4a42-a22f-fbe9dcb683a7 35 fields · synced Jul 15, 2026