510(k) K183039
- Device
- ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- Applicant
- Stryker GmbH
- 510(k) number
- K183039
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-15
- Date received
- 2018-11-01
- 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
- Tina Mornak
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3031914485
- 3010375065
- 2245304
- 9616671
- 3004748528
- 1836116
- 3006721341
- 3014004349
- 1222928
- 3005913274
- 1834379
- 1422572
- 3009141957
- 3005144609
- 3003477135
- 1020279
- 1526350
- 3008868758
- 1000200989
- 3007420745
- 3009888740
- 3005751028
- 3008388276
- 3011015572
- 1226544
- 1054811
- 2030624
- 3014315560
- 3011274144
- 3000264985
- 3004641308
- 1064858
- 3010163695
- 1221934
- 3010039400
- 3017397663
- 1000517406
- 3011189525
- 3007993775
- 3027484613
- 1822565
- 3014302784
- 3014833750
- 3014207283
- 8031020
- 3010057495
- 3010898856
- 2249615
- 1529009
- 3009153862
- 8043792
- 3016851379
- 3015916578
- 3014680795
- 2032521
- 3012725451
- 3014272734
- 1450662
- 3011724582
- 3006128100
- 1827096
- 3013086329
- 3010314800
- 3000931034
- 3006801265
- 1833986
- 3010667733
- 3021008900
- 3013176080
- 3002807310
- 3002907620
- 3002807295
- 3004153896
- 3005130928
- 1057425
- 3010537287
- 1424263
- 1018470
- 3014252644
Source Documents#
Other 510(k) Records For Product Code KWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023-09-26 |
| 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 |
Legacy Summary#
summary