RTS
RTS Flexible 1st MPJ Implant with Grommets, Size 3
4manufacturers in China registered for this device type
10catalogue numbers in this listing
2510(k) clearances naming this product code
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 | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | KWH |
| Device type | Prosthesis, Toe, Constrained, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3720 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K153609 |
| Record published | 2016-11-05 |
| Record revised | 2025-08-04 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M03 S0001 | In distribution | |
| M30 SE030 | In distribution | |
| M30 SE040 | In distribution | |
| M40 SE030 | In distribution | |
| M03 S0003 | In distribution | |
| M30 SE010 | In distribution | |
| M03 S0002 | In distribution | |
| M40 SE020 | In distribution | |
| M30 SE020 | In distribution | |
| M40 SE010 | In distribution |
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 |
| Integra® | Ascension Orthopedics, Inc. | 16 |
| Silicone Toe System | Smith & Nephew, Inc. | 13 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173491 | 2018-02-23 |
| K153609 | 2016-09-08 |
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.