Integra®
The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal…
The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Manufacturer |
| 510(k) | K032686 |
| Record published | 2016-08-15 |
| Record revised | 2023-01-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRL35124L | .945 in dia x 1.027 in H | In distribution |
| TRL35220L | .787 in dia x.620 in H | In distribution |
| TRL35224L | .945 in dia x.702 in H | In distribution |
| TRL35120L | .787 in dia x.945 in H | In distribution |
| TRL35122S | .866 in dia x.789 in H | In distribution |
| TRL35220S | .787 in dia x.420 in H | In distribution |
| TRL31024L | .957 in dia x.623 in H | In distribution |
| TRL35222S | .866 in dia x.464 in H | In distribution |
| TRL31020S | .803 in dia x.423 in H | In distribution |
| TRL35222L | .866 in dia x.664 in H | In distribution |
| TRL31024S | .957 in dia x.423 in H | In distribution |
| TRL31001 | .918 in L x.273 in dia | In distribution |
| TRL31004 | .289 in dia | In distribution |
| TRL31003 | 1.053 in L x.333 in dia | In distribution |
| TRL35124S | .945 in dia x.827 in H | In distribution |
| TRL31022S | .880 in dia x.423 in H | In distribution |
| TRL35122L | .866 in dia x.989 in H | In distribution |
| TRL31002 | .985 in L x.303 in dia | In distribution |
| TRL35224S | .945 in dia x.502 in H | In distribution |
| TRL31022L | .880 in dia x.623 in H | In distribution |
| TRL35120S | .787 in dia x.745 in H | In distribution |
| TRL31020L | .803 in dia x.623 in H | In distribution |
| MRADHDINSTP | 21.9 in L x 10.1 in W x 2.3 in H | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032686 | 2003-10-22 |
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.