KWH · Prosthesis, Toe, Constrained, Polymer
Orthopedic · 21 CFR 888.3720 · Class 2
Overview
| Product Code | KWH |
|---|---|
| Device Name | Prosthesis, Toe, Constrained, Polymer |
| Regulation | 21 CFR 888.3720 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
Classification Rationale
Class II.
Cleared Devices (21)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191966 | NewPrim System | Brm Extremities | Feb 13, 2020 | SESE |
| K190136 | Fusion Silastic System | Fusion Orthopedics, LLC | Oct 21, 2019 | SESE |
| K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | Feb 23, 2018 | SESE |
| K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | Sep 8, 2016 | SESE |
| K102601 | ORTHOFLEX ROD | Ortho-Pro, LLC | Jan 14, 2011 | SESE |
| K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | Nexa Orthopedics, Inc. | Jan 17, 2003 | SESE |
| K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | Nov 26, 2002 | SESE |
| K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | Nov 25, 2002 | SESE |
| K023562 | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | Nov 13, 2002 | SESE |
| K023086 | CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | Oct 4, 2002 | SESE |
| K994326 | ASCENT KNEE SYSTEM | Biomet Manufacturing, Inc. | Jan 7, 2000 | SESE |
| K981194 | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | Jun 30, 1998 | SESE |
| K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT | Smith & Nephew Richards, Inc. | Jul 6, 1995 | SESE |
| K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS | Sutter Corp. | Jun 12, 1995 | SESE |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | May 29, 1991 | SESE |
| K884739 | SGARLATO LESSER TOE IMPLANT | Sgarlato Laboratories, Inc. | May 18, 1989 | SESE |
| K823405 | ZIMMER GREAT TOE | Zimmer, Inc. | Jan 24, 1983 | SESE |
| K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH | Sutter Biomedical, Inc. | May 21, 1982 | SESE |
| K801345 | KAMPNER HINGED TOE PROSTHESIS | Biomedics | Jul 8, 1980 | SESE |
| K801094 | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL | Dow Corning Corp. Healthcare Industries Materials | Jun 9, 1980 | SESE |
| K780132 | IMPLANT, HINGE TOE, FLEX. | Dow Corning Corp. Healthcare Industries Materials | Feb 6, 1978 | SESE |
Top Applicants
- Nexa Orthopedics, Inc. — 4 clearances
- Sgarlato Laboratories, Inc. — 2 clearances
- Osteomed Corp. — 2 clearances
- In2bones USA, LLC — 2 clearances
- Dow Corning Corp. Healthcare Industries Materials — 2 clearances
