ClearanceBrief
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)
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Top companies in KWI

DateFirm and productCodeLinked 510(k)
Oct 4, 2022Wright 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
KWIK060731
K991915
Oct 4, 2022Wright 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
KWIK060731
K991915
Apr 7, 2022Synthes (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
KWIK183618
Aug 26, 2020Wright Medical Technology Inc
EVOLVE STEM 8.5MM Model # 496S085
Terminated
KWIK060731
K991915
Dec 27, 2019Wright Medical Technology, Inc.
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Terminated
KWIK060731
Dec 27, 2019Wright Medical Technology, Inc.
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Terminated
KWIK060731
Oct 24, 2017Howmedica 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
KWIK023604
Oct 24, 2017Howmedica 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
KWIK023604
Oct 24, 2017Howmedica 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
KWIK023604
Oct 24, 2017Howmedica 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
KWINone listed
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Oct 24, 2017Howmedica 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
KWIK062898
Jun 16, 2017Zimmer 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
KWIK051385
Apr 20, 2017Acumed 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
KWIK131845
Dec 29, 2016Synthes (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
KWIK112030
Dec 12, 2014Skeletal 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
KWIK092721
May 13, 2014Biomet, Inc.
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Terminated
KWIK040611
K051385
Oct 29, 2013Small 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
KWIK002644
K010786 +4
May 3, 2013Synthes 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
KWIK112030

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