3DMetal Diaphyseal Femoral Cones

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: 3DMetal Diaphyseal Femoral Cones FDA UDI
Generic Name: Knee arthroplasty wedge FDA UDI
Device Name: 3DMetal Diaphyseal Femoral Cone Size Small FDA UDI
Model / Reference: 02.07.FCS20 FDA UDI
Description: 3DMetal Diaphyseal Femoral Cone Size Small FDA UDI

Identifiers

Primary DI / UDI-DI: 07630971259232 FDA UDI
510(k) Number: K200075 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Knee arthroplasty wedge 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: Knee arthroplasty wedge

3DMetal Diaphyseal Femoral Cones by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee arthroplasty wedge.

NexGen® — Zimmer, Inc. · Class II
ADVANCE® — MicroPort Orthopedics Inc. · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
LEGION — Smith & Nephew, Inc. · Class II
ADVANTIM® — MicroPort Orthopedics Inc. · Class II
LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
Unity Total Knee System — CORIN LTD · Class II
ADVANCE® — MicroPort Orthopedics Inc. · Class II

Cleared under the same submission

K200075 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: Medacta International

Sources (1)

FDA UDI f5d1fa1a-e42c-4000-90c3-bf1e1ba70443 34 fields · synced Jun 8, 2026