510(k) K172054
- Device
- Materialise Glenoid Positioning System
- Applicant
- Materialise NV
- 510(k) number
- K172054
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-03
- Date received
- 2017-07-06
- 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
- Oliver Clemens
- Address
- Technologielaan 15 Leuven BE 3001 3001
FDA Registration Numbers#
- 3010057495
- 1649518
- 1529009
- 3004371426
- 3009423112
- 3008395353
- 3020704423
- 3005718816
- 3012319330
- 3009555447
- 2028632
- 3009555440
- 1018470
- 3003916006
- 9615014
- 3002806603
- 1833506
- 2245304
- 1835831
- 1834379
- 3012470322
- 1043534
- 3004976965
- 3025603301
- 3010363503
- 1054811
- 3007441485
- 3011724582
- 3015806723
- 3004154314
- 3014262693
- 3002806470
- 2528981
- 9681465
- 3012755988
- 3013561205
- 2032521
- 3013014058
- 1833986
- 3009116370
- 1836116
- 3002807310
- 3005751028
- 1064858
- 3006128100
- 3010287737
- 3011274144
- 3009941480
- 3011189525
- 3012552981
- 3007420745
- 9617083
- 3003387384
- 3007923096
- 3015207155
- 3009871135
- 3011061242
- 3012818475
- 3020967480
- 1721676
- 3007740680
- 3009973844
- 8010916
- 1643264
- 3012725451
- 3016090213
- 1000517406
- 1020279
- 3010400367
- 3005180920
- 3014302784
- 3000931034
- 3015542154
- 9614841
- 3010065126
- 9613350
- 1038671
- 3008868758
- 1649390
- 8010379
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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