510(k) K181287
- Device
- Catalyst CSR Shoulder System
- Applicant
- Catalyst OrthoScience, Inc.
- 510(k) number
- K181287
- Product code
- KWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-12
- Date received
- 2018-05-16
- Regulation
- 888.3650
- Classification name
- Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dale Davison
- Address
- 14710 Tamiami Trl., N. Suite 102 Naples FL US 34110 34110
FDA Registration Numbers#
- 1000517406
- 3005061536
- 3002808022
- 3008658204
- 3010047402
- 3004513872
- 3010383847
- 1644408
- 3010287737
- 9616671
- 1226544
- 3035366890
- 3026771806
- 3009417901
- 3008868758
- 3004371426
- 3007923096
- 1422572
- 3010386387
- 1649518
- 1827096
- 3011189525
- 1721676
- 3010375065
- 1818910
- 9681465
- 3009546990
- 1000200989
- 3006563559
- 3010370880
- 1828288
- 1529009
- 3010178296
- 2133928
- 3012544635
- 3009116370
- 3012523063
- 1649390
- 3002807295
- 3004748528
- 3007993775
- 3015916578
- 1423662
- 2528981
- 3014128390
- 3020745236
- 3011061242
- 3006001176
- 3012319330
- 3009475821
- 2249615
- 3008021110
- 3012552981
- 3006984710
- 3009973844
- 3011015572
- 3010057495
- 1221934
- 3015516266
- 3009973505
- 3008337808
- 8043792
- 3015399803
- 3010065126
- 2030624
- 1057425
- 3007051929
- 3012725451
- 3004983210
- 3025603301
- 1424263
- 3009532798
- 9613350
- 3009153862
- 9611390
- 1834331
- 3009871135
- 3008388276
- 3006801265
- 3010314800
Source Documents#
Other 510(k) Records For Product Code KWT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. | 2025-12-01 |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025-10-30 |
| K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025-03-10 |
| K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025-02-11 |
| K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024-02-16 |
| K223631 | Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics | 2023-07-12 |
| K222482 | AGILON XO Shoulder System | Implantcast GmbH | 2022-09-28 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021-06-21 |
| K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | 2020-07-16 |
| K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019-11-29 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019-09-11 |
| K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019-01-11 |
| K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | 2018-03-09 |
| K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | Exactech, Inc. | 2017-02-27 |
Legacy Summary#
summary
FDA Review#
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