510(k) K261576
- Device
- Icona Hip Stem
- Applicant
- Corin, Ltd.
- 510(k) number
- K261576
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-10
- Date received
- 2026-05-12
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Aaron Brunt
- Address
- The Corinium Centre Cirencester GB GL7 1YJ GL7 1YJ
FDA Registration Numbers#
- 1226188
- 1000550978
- 3007913880
- 9615674
- 3005497913
- 8010379
- 1221053
- 1828288
- 3005551626
- 1220477
- 3035366890
- 3012329926
- 3004153240
- 3013055499
- 3010097171
- 1018470
- 3010576282
- 3008812251
- 1825034
- 3010314800
- 3002807295
- 3007366790
- 3008668801
- 3006801265
- 3005718816
- 3001278222
- 3021008900
- 3008102042
- 3010206549
- 3010386387
- 3003639920
- 3010163695
- 3009871135
- 8044172
- 3042508254
- 3005061536
- 3003998208
- 3007391088
- 3008556682
- 2133928
- 3006001176
- 9681642
- 3015516266
- 3001284227
- 1720929
- 9610612
- 3006128100
- 1043653
- 1526711
- 3014833750
- 2245304
- 9681465
- 3030338875
- 1450662
- 1219655
- 1643817
- 3026771806
- 3000236920
- 3004976965
- 3009888740
- 3036756245
- 3004371426
- 3006946276
- 3011295718
- 3002807310
- 3021386586
- 3015259876
- 3005180920
- 3038503932
- 3002806535
- 3004748528
- 3006946279
- 3009475821
- 3034676720
- 3009973336
- 3010220595
- 3009732568
- 3016438761
- 3009760038
Source Documents#
Other 510(k) Records For Product Code MEH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025-11-05 |
| K251166 | Mfinity Femoral System | Medacta International S.A. | 2025-06-13 |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025-05-22 |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | 2025-05-01 |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025-03-10 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024-11-25 |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024-10-03 |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024-09-13 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024-08-01 |
| K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024-03-08 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional | Depuy Ireland UC | 2024-01-19 |
| K231178 | ACTERA™ hip system | Conformis, Inc. | 2023-05-23 |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023-01-13 |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022-08-11 |
| K221104 | Actera™ hip system | Conformis, Inc. | 2022-08-04 |