510(k) K994366
- Device
- TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
- Applicant
- HOWMEDICA OSTEONICS CORP.
- 510(k) number
- K994366
- Product code
- MEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-16
- Date received
- 1999-12-27
- 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
- No
Applicant Contact#
- Contact
- NANCY J RIEDER
- Address
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers#
- 3010375065
- 2245304
- 9616671
- 3004748528
- 3009173317
- 1526711
- 3005913274
- 3016438694
- 3005562917
- 3011295718
- 1020279
- 3008868758
- 3009888740
- 3005551626
- 1000550978
- 1226544
- 3008824097
- 3002806535
- 8044172
- 3010220595
- 3010163695
- 3006809628
- 3010206549
- 1822565
- 3009973336
- 3036773273
- 1722511
- 3014302784
- 3014833750
- 3000236920
- 3020155054
- 3010057495
- 2249615
- 1529009
- 8043792
- 9614209
- 3012725451
- 1000547811
- 9681642
- 3014272734
- 3016438761
- 3008102042
- 1450662
- 1221763
- 3000196378
- 3012329926
- 3006128100
- 3010576282
- 9613369
- 3010314800
- 3006801265
- 3004153240
- 3021008900
- 3010097171
- 3013176080
- 3002807315
- 3002807310
- 3022142628
- 3002907620
- 3002807295
- 3004153896
- 2531477
- 1018470
- 3009760038
- 3010386387
- 3015516266
- 1219655
- 3009871135
- 1043653
- 3026771806
- 3010178296
- 1720929
- 3003998208
- 3007913880
- 3003387384
- 1644408
- 3009546990
- 3013014058
- 3033509898
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 |
Legacy Summary#
summary
FDA Review#
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