Panels › Orthopedic › Product code KWI · Class 2
Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation 888.3170
1510(k)s in 12 months (34 all time)
0recalls in 12 months (30 all time)
29recalls that name a 510(k)
Top companies in KWI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2022 | Wright Medical Technology, Inc. stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It Open, Classified |
KWI | K060731 K991915 |
| Oct 4, 2022 | Wright Medical Technology, Inc. stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It co Open, Classified |
KWI | K060731 K991915 |
| Apr 7, 2022 | Synthes (USA) Products LLC Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diamet Open, Classified |
KWI | K183618 |
| Aug 26, 2020 | Wright Medical Technology Inc EVOLVE STEM 8.5MM
Model # 496S085 Terminated |
KWI | K060731 K991915 |
| Dec 27, 2019 | Wright Medical Technology, Inc. WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 Terminated |
KWI | K060731 |
| Dec 27, 2019 | Wright Medical Technology, Inc. WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 Terminated |
KWI | K060731 |
| Oct 24, 2017 | Howmedica Osteonics Corp. #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K023604 |
| Oct 24, 2017 | Howmedica Osteonics Corp. #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K023604 |
| Oct 24, 2017 | Howmedica Osteonics Corp. #2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K023604 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | None listed |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Oct 24, 2017 | Howmedica Osteonics Corp. Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated |
KWI | K062898 |
| Jun 16, 2017 | Zimmer Biomet, Inc. ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610.
The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed Terminated |
KWI | K051385 |
| Apr 20, 2017 | Acumed LLC The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants Terminated |
KWI | K131845 |
| Dec 29, 2016 | Synthes (USA) Products LLC Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories
Product Usage:
Intended for primary and revision joint replacement of the radial head. Terminated |
KWI | K112030 |
| Dec 12, 2014 | Skeletal Dynamics Align Radial Stems, Prosthesis, Elbow, Hemi
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/o Terminated |
KWI | K092721 |
| May 13, 2014 | Biomet, Inc. ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant. Terminated |
KWI | K040611 K051385 |
| Oct 29, 2013 | Small Bone Innovations, Inc. Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Later Terminated |
KWI | K002644 K010786 +4 |
| May 3, 2013 | Synthes USA HQ, Inc. Synthes Radial Head Prosthesis: Trial Radial Head
Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome compon Terminated |
KWI | K112030 |
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