Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Cruciate-retaining total knee prosthesis FDA UDI
Device Name: INSERT, 3D SIZE3 R 13MM FDA UDI
Model / Reference: 392-13-003 FDA UDI
Description: INSERT, 3D SIZE3 R 13MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00888912336390 FDA UDI
510(k) Number: K020114 FDA UDI
FDA Product Code: JWH 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

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

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

FDA UDI

Category: Tibial insert Cruciate-retaining total knee prosthesis

The DJO SURGICAL knee replacement device is a cutting-edge, implantable artificial substitute for a damaged or degenerative knee joint. Designed to provide superior stability and articulation, it features a one-piece contoured polyethylene insert or a more complex guide arm with stem and polymer glide. This device is ideal for patients requiring a cruciate-retaining total knee prosthesis, particularly those with good bone stock and adequate supporting ligaments.

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
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
STERIZO Total Knee System — CPM Medical Consultants, LLC · Class II
Arthrex® — Arthrex, Inc. · 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: Encore Medical, L.p.

Sources (1)

FDA UDI 8c09d814-cc23-4cd2-8d80-ee7cea8844c4 34 fields · synced Jul 5, 2026