510(k) K031449
- Device
- MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
- Applicant
- IMPLEX CORP.
- 510(k) number
- K031449
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-23
- Date received
- 2003-05-07
- 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
- ROBERT A POGGIE
- Address
- 80 Commerce Dr. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 1038671
- 3006085220
- 3011189525
- 3005751028
- 1649518
- 3003998208
- 2249615
- 9614841
- 3002579136
- 3013791180
- 3006721341
- 3012319330
- 9615014
- 3009546990
- 3014302784
- 3013552417
- 1644408
- 9616671
- 1226544
- 3013014058
- 3004641308
- 2245304
- 3011061242
- 1043534
- 3013561205
- 3010537287
- 3009555440
- 3002806470
- 3025603301
- 3033509898
- 3004748528
- 3010400367
- 3013700547
- 1828288
- 3014833750
- 3010331645
- 9680515
- 3007441485
- 1836357
- 1721676
- 3005061536
- 1526534
- 3012755988
- 2028632
- 2032521
- 3010097171
- 9611390
- 3006128100
- 1422572
- 3010383847
- 3009882462
- 3003403260
- 3006849754
- 8010177
- 3003916006
- 3006017180
- 1833986
- 3010041693
- 3019269298
- 3020704423
- 3008395353
- 8010916
- 9615674
- 3008021110
- 1220246
- 3006946276
- 3014262693
- 3010009693
- 1219655
- 3000931034
- 3008556682
- 3015542154
- 3008337808
- 3002806603
- 9616680
- 3010173425
- 1018470
- 3005596372
- 3020967480
- 3003755939
Source Documents#
Other 510(k) Records For Product Code KWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263583 | Tornier Humeral Reconstruction System (HRS) Tuberosity Body | Tornier, Inc. | 2026-10-28 |
| 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 |
Legacy Summary#
summary
FDA Review#
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