510(k) K243839
- Device
- Alteon® HA Femoral Stems
- Applicant
- Exactech, Inc.
- 510(k) number
- K243839
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-10
- Date received
- 2024-12-13
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Pedro Ravelo
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers
- 1450662
- 3000236920
- 2242737
- 3005180920
- 2133928
- 3007913880
- 1000547811
- 3013176080
- 3002807315
- 3021008900
- 3010386387
- 3010057495
- 3006801265
- 1835831
- 3009871135
- 3012275107
- 8044172
- 1644408
- 3023852420
- 1834331
- 1226188
- 1018470
- 3010287737
- 3005323511
- 3006809628
- 3025603301
- 3009760038
- 3030338875
- 3005061536
- 3014170143
- 3010163695
- 3034676720
- 1643264
- 3006946279
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3014763043
- 3007740680
- 3002806535
- 1721676
- 3015516266
- 3009475821
- 3010041693
- 3012916784
- 3006395932
- 1218882
- 3004976965
- 3002807314
- 3004153896
- 3013302242
- 3007923096
- 3015259876
- 3013014058
- 3021386586
- 9613350
- 2249697
- 3012392319
- 3012523063
- 3010288357
- 3016438694
- 3009973336
- 3008110533
- 3010097171
- 9615800
- 3006128100
- 3002907620
- 3002808022
- 3004153240
- 3038503932
- 3010155661
- 1649518
- 9681465
- 3001278222
- 3015167917
- 3005562917
- 9681642
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| 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 |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022-01-07 |