Accuris

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: ACCURIS FDA UDI
Generic Name: Uncoated knee tibia prosthesis, polyethylene FDA UDI
Device Name: ACCURIS-TIBIA INSRT TRIAL MEDIUM/LARGE 12 FDA UDI
Model / Reference: 71236412 FDA UDI
Description: ACCURIS-TIBIA INSRT TRIAL MEDIUM/LARGE 12 FDA UDI

Identifiers

Catalog Number: 71236412 FDA UDI
Primary DI / UDI-DI: 03596010477033 FDA UDI
510(k) Number: K113038 FDA UDI
FDA Product Code: HSX FDA UDI
GMDN Term: Uncoated knee tibia prosthesis, polyethylene FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Uncoated knee tibia prosthesis, polyethylene

Accuris by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia prosthesis, polyethylene.

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World Knee Vit-E CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Freedom — MAXX ORTHOPEDICS INC. · Class II
Gemini SL — WALDEMAR LINK GmbH & Co. KG · Class II
Triathlon — Howmedica Osteonics Corp. · Class II
Freedom — MAXX ORTHOPEDICS INC. · Class II
Freedom — MAXX ORTHOPEDICS INC. · Class II
GMK Primary Total Knee System — Medacta International · Class II

Cleared under the same submission

K113038 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI cb91328c-a1b2-41d8-a13f-66d9014ed122 36 fields · synced Jun 8, 2026