Home › Ascension Orthopedics, Inc. › Integra® BioMotion® Cannulated Hemi System
Integra® BioMotion® Cannulated Hemi System
Ascension Orthopedics, Inc. · Model BIOMOTIONIMP · UDI-DI 10381780074274
KWD
Prescription
1
510(k) clearances
294
Adverse events
14
Recalls
49
Facilities
Description
The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first metatarsophalangeal joint (MPJ). Implants are available in sizes ranging from 15mm to 23mm. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The BioMotion hemi implant is indicated for use in the treatment of degenerative arthritis in the first MPJ along with hallux limitus/rigidus, hallux valgus and pain or instability.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-04 | restor3d Inc. | Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
| 2022-02-01 | BioPro, Inc. | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.