Integra®
LMP Implant Size 20 The Integra® Lesser Metatarsal Phalangeal Joint Implant is the first prosthesis designed specifically to supplement lesser metatarsal phalangeal joint arthroplasty.…
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.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | KWH |
| Device type | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3720 |
| Establishment | Manufacturer |
| 510(k) | K023562 |
| Record published | 2016-07-25 |
| Record revised | 2023-05-02 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CGT-20T | 20 | In distribution |
| CGT-40T | 40 | In distribution |
| LMP-20T | 20 | In distribution |
| FGT-30T | 30 | In distribution |
| FGT-40T | 40 | In distribution |
| CGT-60T | 60 | In distribution |
| FGT-20T | 20 | In distribution |
| CGT-30T | 30 | In distribution |
| CGT-50T | 50 | In distribution |
| LMP-30T | 30 | In distribution |
| LMP-50T | 50 | In distribution |
| LMP-40T | 40 | In distribution |
| FGT-50T | 50 | In distribution |
| LMPSRT | Withdrawn | |
| FGTSRT | Withdrawn | |
| CGTSRT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Profix | Smith & Nephew, Inc. | 138 |
| Sgarlato Silastic | Fusion Orthopedics, LLC | 51 |
| Swanson | Wright Medical Technology, Inc. | 29 |
| Silicone Toe System | Smith & Nephew, Inc. | 13 |
| RTS | IN2BONES USA, LLC | 10 |
| Ascent Knee System | Biomet Orthopedics | 10 |
| Silktoe Spacer | BRM Extremities SRL | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 7 |
| OsteoMed | Osteomed | 6 |
| Futura™ FDI | Tornier Inc. | 6 |
| Futura™ CGT | Tornier Inc. | 5 |
| Orthoflex | Wright Medical Technology, Inc. | 4 |
Showing 12 of 14. All products under Prosthesis, Toe, Constrained, Polymer
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Tornier Inc. | 510(k) number | 2009-04-06 | Not classified | Labeling mix-ups | Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great T | 77 | 2011-12-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.