Panels › Orthopedic › Product code JDB · Class 2

Prosthesis, Elbow, Semi-Constrained, Cemented

Regulation 888.3160

0510(k)s in 12 months (27 all time)

0recalls in 12 months (26 all time)

26recalls that name a 510(k)

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Top companies in JDB

Company	510(k)s	Recalls
Howmedica Osteonics Corp.	0	18
Tornier	9	2
Depuy, Inc.	3	0
Small Bone Innovations, Inc.	3	0
Stryker Howmedica Osteonics Corp.	0	3
Depuy Orthopaedics, Inc.	0	2
Howmedica Corp.	2	0
Johnson & Johnson Professionals, Inc.	2	0
Wrightmedicaltechnologyinc	2	0
Zimmer, Inc.	2	0

Date	Firm and product	Code	Linked 510(k)
Apr 22, 2025	Tornier, Inc stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented Open, Classified	JDB	K100562
Dec 20, 2024	Limacorporate S.p.A TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis. Open, Classified	JDB	K222807
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K102180
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Oct 24, 2017	Howmedica Osteonics Corp. Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Terminated	JDB	K060038
Aug 20, 2015	Stryker Howmedica Osteonics Corp. Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius. Terminated	JDB	K102180
Aug 20, 2015	Stryker Howmedica Osteonics Corp. Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients. Terminated	JDB	K070236
Aug 20, 2015	Stryker Howmedica Osteonics Corp. rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius. Terminated	JDB	K102180
Aug 29, 2011	Tornier, Inc Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis Terminated	JDB	K100562
Feb 16, 2006	Depuy Orthopaedics, Inc. Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000. Terminated	JDB	K992656
Feb 16, 2006	Depuy Orthopaedics, Inc. Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000. Terminated	JDB	K992656

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