FDA.reportPublic FDA data

510(k) K241878

Device
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Applicant
Stryker Corporation (Tornier, Inc.)
510(k) number
K241878
Product code
KWS
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-06
Date received
2024-06-28
Regulation
888.3660
Classification name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stefanie Tarara
Address
10801 Nesbitt Ave. S. Bloomington MN US 55437 55437

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.2026-04-06
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K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)2024-09-10
K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.2023-09-26
K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.2023-06-23
K230572AETOS Shoulder SystemSmith & Nephew, Inc.2023-06-07
K220847AETOS Shoulder SystemSmith & Nephew, Inc.2023-01-03
K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.2022-11-10
K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.2022-07-07
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K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.2022-03-04
K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.2021-12-10