Engage Partial Knee System

FDA UDI

Class II (US FDA UDI)

by Engage Uni, LLC

Identity

Trade Name: Engage Partial Knee System FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: Tension Gauge FDA UDI
Model / Reference: 1-50078-000 FDA UDI
Description: Tension Gauge FDA UDI

Identifiers

Primary DI / UDI-DI: B6951500780000 FDA UDI
510(k) Number: K190439 FDA UDI
FDA Product Code: NJD FDA UDI
HSX FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3535 FDA UDI
888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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Convenience Kit

FDA UDI

Combination Product

FDA UDI

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: Joint prosthesis implantation kit, reusable

The Engage Partial Knee System is a comprehensive joint prosthesis solution designed for individuals seeking to enhance mobility and quality of life. This fully implantable knee system features a tension gauge, ensuring precise control over the prosthetic's movement. The device is available in various configurations, catering to different user needs.

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Initia Total Hip System — Kyocera Corporation · Class II
PROPHECY — MicroPort Orthopedics Inc. · Class II
Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
Evolution — MicroPort Orthopedics Inc. · Class II
GUARDIAN® — MicroPort Orthopedics Inc. · Class I
ADVANCE® — MicroPort Orthopedics Inc. · Class I
PROPHECY — MicroPort Orthopedics 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: Engage Uni, LLC

Sources (1)

FDA UDI 44597478-f5db-4d02-98b8-0c2c5504a063 35 fields · synced Jul 31, 2026