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Integra®

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
Device Name
LMP Implant Size 20 The Integra® Lesser Metatarsal Phalangeal Joint Implant is the first prosthesis designed specifically to supplement lesser metatarsal phalangeal joint arthroplasty. Constructed of medical grade silicone elastomer, the implant features stems designed to fit the intramedullary canals of the proximal phalanx and the lesser metatarsal. The LMP is offered in four sizes and is supported by a custom instrumentation set. FDA UDI
Model / Reference
LMP-20T FDA UDI
Description
LMP Implant Size 20 The Integra® Lesser Metatarsal Phalangeal Joint Implant is the first prosthesis designed specifically to supplement lesser metatarsal phalangeal joint arthroplasty. Constructed of medical grade silicone elastomer, the implant features stems designed to fit the intramedullary canals of the proximal phalanx and the lesser metatarsal. The LMP is offered in four sizes and is supported by a custom instrumentation set. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780257660 FDA UDI
510(k) Number
K023531 FDA UDI
FDA Product Code
KWH FDA UDI
GMDN Term
Total metatarsophalangeal joint prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3720 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total metatarsophalangeal joint prosthesis, one-piece

Integra® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total metatarsophalangeal joint prosthesis, one-piece.

Cleared under the same submission

K023531 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI a023bf4e-5bc4-4a10-b8c8-a5e7cd861b97 37 fields · synced Jun 8, 2026