Panels › Orthopedic › Product code KWD · Class 2
Prosthesis, Toe, Hemi-, Phalangeal
Regulation 888.3730
1510(k)s in 12 months (46 all time)
1recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in KWD
| Company | 510(k)s | Recalls |
|---|---|---|
| Biopro, Inc. | 3 | 10 |
| Arthrosurface, Inc. | 5 | 0 |
| Solana Surgical, LLC | 4 | 0 |
| Orthopro, LLC | 2 | 1 |
| Osteomed LP | 3 | 0 |
| Vilex, Inc. | 3 | 0 |
| Accufix Surgical, Inc. | 2 | 0 |
| Ascension Orthopedics, Inc. | 2 | 0 |
| BioPoly, LLC | 2 | 0 |
| Restor3D, Inc. | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | restor3d Inc. Generic Name: restor3d MTP Implant
Generic Name: MTP Implant
Model/Catalog Number: 1103-161620
Software Version: None
Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, Open, Classified |
KWD | K201393 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 Terminated |
KWD | K041595 |
| Feb 1, 2022 | BioPro, Inc. Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 Terminated |
KWD | K041595 |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 Terminated |
KWD | K864492 |
| Dec 16, 2014 | Integra LifeSciences Corp. Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic art Terminated |
KWD | K060560 |
| Sep 18, 2008 | OrthoPro LLC Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplas Terminated |
KWD | K071243 |
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