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: Cruciate-retaining total knee prosthesis FDA UDI
Device Name: L CR Cemented Femoral Component Sz 2 FDA UDI
Model / Reference: A 200 FDA UDI
Description: L CR Cemented Femoral Component Sz 2 FDA UDI

Identifiers

Catalog Number: 1201-112-200 FDA UDI
Primary DI / UDI-DI: 00841523100774 FDA UDI
510(k) Number: K120038 FDA UDI
FDA Product Code: JWH FDA UDI
OIY FDA UDI
GMDN Term: Cruciate-retaining total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 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: Cruciate-retaining total knee prosthesis

Kyocera Medical Technologies, Inc. by Kyocera Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cruciate-retaining total knee prosthesis.

Arthrex® — Arthrex, Inc. · Class II
Columbus® UC — AESCULAP, INC. · Class II
Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC · Class II
UKNEE Tibial insert, plained — UNITED ORTHOPEDIC CORP. · Class II
B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II

Cleared under the same submission

K120038 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kyocera Medical Technologies, Inc.

Sources (1)

FDA UDI 7902aa59-4b45-4fa4-ba2a-6f8398694caa 35 fields · synced May 30, 2026