Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Knee tibia prosthesis trial, reusable FDA UDI
Device Name: SPECIALTY TRIATHLON TRIAL BASEPLATE FDA UDI
Model / Reference: I-K2737BP08 FDA UDI
Description: SPECIALTY TRIATHLON TRIAL BASEPLATE FDA UDI

Identifiers

Catalog Number: I-K2737BP08 FDA UDI
Primary DI / UDI-DI: 07613327316049 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
NPJ FDA UDI
KRR FDA UDI
HRY FDA UDI
HSX FDA UDI
GMDN Term: Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 FDA UDI
888.3540 FDA UDI
888.3530 FDA UDI
888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee tibia prosthesis trial, reusable

A comprehensive specialty triathlon trial baseplate designed to determine the correct alignment, size, and fit of final prostheses for unicompartmental knee replacement surgery or total knee arthroplasty (TKA). This reusable device is made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, etc.

Similar devices

Also classified as Knee tibia prosthesis trial, reusable.

JOURNEY — Smith & Nephew, Inc. · Class II
U2™ Knee — UNITED ORTHOPEDIC CORP. · Class II
ACS® — implantcast GmbH · Class I
SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
NexGen® Trabucular Metal® — Zimmer, Inc. · Class I
NexGen® Legacy® — Zimmer, Inc. · Class I
JOURNEY — Smith & Nephew, Inc. · Class I

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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI ca8fc706-e43b-4dfa-91fe-daa55832db7d 35 fields · synced Jul 30, 2026