510(k) K203315
- Device
- BLUEPRINT™ Patient Specific Instrumentation
- Applicant
- Tornier SAS
- 510(k) number
- K203315
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-15
- Date received
- 2020-11-10
- 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
- Aymen Azaiez
- Address
- 161 Rue Lavoisier Montbonnot-Saint-Martin FR 38330 38330
FDA Registration Numbers#
- 3008556682
- 3012818475
- 3003916006
- 3008868758
- 1822565
- 3002579136
- 1057425
- 8043792
- 3010287737
- 3014302784
- 3014833750
- 3021008900
- 3016090213
- 1835572
- 3006356043
- 1226544
- 3008837339
- 3007366790
- 3019807891
- 3002806603
- 3006801265
- 3010047402
- 3005180920
- 2244478
- 3007993775
- 1644408
- 3006946276
- 3013302242
- 3009887475
- 3003477135
- 3010898856
- 3015806723
- 3010065126
- 9613350
- 3004976965
- 3012552981
- 3008395353
- 3009871135
- 3006085220
- 3033509898
- 3006017180
- 3006984710
- 3002807310
- 3010057495
- 3003998208
- 3005596372
- 3010400367
- 3006563559
- 3010667733
- 3007740680
- 3017397663
- 3011189525
- 1833986
- 3010009693
- 3010375065
- 9611390
- 1835831
- 3008658204
- 3009555447
- 3002806470
- 3036756245
- 3013700547
- 3011015572
- 3013791180
- 3011724582
- 1018470
- 3000931034
- 3014027736
- 8031020
- 8010379
- 3048515471
- 3004154314
- 3010039400
- 3012275107
- 1836116
- 1828288
- 1038671
- 3010178296
- 3015207155
- 3009888740
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#
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FDA Review#
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