ClearanceBrief
Panels › Orthopedic › Product code HSD · Class 2

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Regulation 888.3690

0510(k)s in 12 months (71 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
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Top companies in HSD

DateFirm and productCodeLinked 510(k)
Nov 9, 2020Exactech, Inc.
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Open, Classified
HSDK042021
Nov 16, 2018Ascension Orthopedics, Inc
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Terminated
HSDK062861
Jun 4, 2018Fx Solutions
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions suscept
Terminated
HSDK111097
Jun 4, 2018Fx Solutions
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susce
Terminated
HSDK111097
Dec 8, 2017Zimmer Biomet, Inc.
Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Terminated
HSDK060692
Dec 8, 2017Zimmer Biomet, Inc.
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Terminated
HSDK060692
Aug 31, 2017DePuy Orthopaedics, Inc.
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional ro
Terminated
HSDK120174
Sep 2, 2015Limacorporate S.p.A
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
Terminated
HSDK100858
Feb 12, 2015Arthrosurface, Inc.
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic sh
Terminated
HSDK023096
Feb 12, 2015Arthrosurface, Inc.
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic should
Terminated
HSDK023096
Feb 12, 2015Arthrosurface, Inc.
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulde
Terminated
HSDK023096
Feb 12, 2015Arthrosurface, Inc.
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shou
Terminated
HSDK023096
Feb 12, 2015Arthrosurface, Inc.
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoul
Terminated
HSDK023096
Jul 10, 2013Zimmer, Inc.
Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. h
Terminated
HSDK110791
Apr 17, 2013Synvasive Technology Inc
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System
Terminated
HSDK911902
Nov 12, 2009Zimmer Inc.
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.
Terminated
HSDK041549
Nov 12, 2009Zimmer Inc.
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
Terminated
HSDK041549
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Reunion HA Fracture Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total
Terminated
HSDK070963
Dec 11, 2008Acumed LLC
Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "
Terminated
HSDK992525

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