510(k) K230513
- Device
- Arthrex Univers Apex OptiFit Humeral Stem
- Applicant
- Arthrex, Inc.
- 510(k) number
- K230513
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-26
- Date received
- 2023-02-24
- 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
- Tiffany Mentzel
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3014272734
- 3020967480
- 1833506
- 1836357
- 1000200989
- 3006849754
- 1226544
- 3027484613
- 1038671
- 3009871135
- 3010047402
- 3013302242
- 1828464
- 1220477
- 1221934
- 1043534
- 3010331645
- 3009116370
- 3000264985
- 3007993775
- 3010163695
- 3015516266
- 9617083
- 3009882462
- 3006801265
- 3010386387
- 3004513872
- 3011274144
- 2249697
- 9616680
- 3003898228
- 3019269298
- 3009475821
- 3014262693
- 1835572
- 3013700547
- 1818910
- 9614841
- 3005180920
- 3002808022
- 2183946
- 3010039400
- 3010375065
- 3009241418
- 3003916006
- 3008395353
- 3013055499
- 3005144609
- 3006563559
- 3011061242
- 3007420745
- 1529009
- 1018470
- 3005751028
- 3021566676
- 9680515
- 3015916578
- 3011724582
- 3004153896
- 3005718816
- 3010898856
- 3010537287
- 9613350
- 2245304
- 3004371426
- 2528981
- 3015542154
- 3012275107
- 3012755988
- 3010287737
- 3011015572
- 3010383847
- 3003403260
- 3010065126
- 3017397663
- 3008110533
- 9616944
- 1833986
- 3013014058
- 3002579136
Source Documents#
Other 510(k) Records For Product Code KWS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | 2026-07-22 |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2023-06-23 |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-07 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022-07-07 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | 2022-03-11 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |