Jts Extendible Distal Femoral Implant

FDA UDI

Class II (US FDA UDI)

by Onkos Surgical, Inc.

Identity

Trade Name: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT FDA UDI
Generic Name: Uncoated knee femur prosthesis, metallic FDA UDI
Device Name: JTS Distal Femur Left STD FDA UDI
Model / Reference: JTSDF-L-STD FDA UDI
Description: JTS Distal Femur Left STD FDA UDI

Identifiers

Catalog Number: JTSDF-L-STD FDA UDI
Primary DI / UDI-DI: B278JTSDFLSTD0 FDA UDI
510(k) Number: K092138 FDA UDI
K133152 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 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

MRI Safety

MR Unsafe FDA UDI

Category: Uncoated knee femur prosthesis, metallic

Jts Extendible Distal Femoral Implant by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Uncoated knee femur prosthesis, metallic.

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LEGION — Smith & Nephew, Inc. · Class II
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Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
GMK Sphere Revision System — Medacta International · Class II
ACS® — implantcast GmbH · Class II
Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · 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: Onkos Surgical, Inc.

Sources (1)

FDA UDI 2e2fc39e-7997-4f2f-be8b-d835f0a19bfa 36 fields · synced May 30, 2026