510(k) K133370
- Device
- REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
- Applicant
- SIGNATURE ORTHOPAEDICS PTY LIMITED
- 510(k) number
- K133370
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-22
- Date received
- 2013-11-04
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DECLAN BRAZIL
- Address
- 7 Sirius Rd. Ln. Cove Nsw AU 2066 2066
FDA Registration Numbers#
- 3002807408
- 1000550978
- 3003061090
- 1225675
- 1218882
- 9616680
- 3020967480
- 3006128100
- 8010379
- 3000258338
- 3007200272
- 2528981
- 3022142628
- 9610612
- 3014763043
- 2244478
- 3026776
- 1835444
- 1423662
- 3012119238
- 3021008900
- 3004986960
- 3007740680
- 3010846112
- 3002807314
- 3016778562
- 1226188
- 3010287737
- 3005323511
- 3033509898
- 3008110533
- 3009813841
- 3009760038
- 3010047454
- 3010041993
- 3007189546
- 3005562917
- 3008668801
- 2648920
- 1047843
- 3015398319
- 3002907620
- 1530390
- 2032521
- 3000196378
- 3026771806
- 3009973505
- 1043653
- 3012755988
- 1048735
- 3004371426
- 1221053
- 2249697
- 3008868758
- 3014315560
- 1644408
- 2245304
- 3001284227
- 3006395932
- 3017410889
- 3018052045
- 3002807090
- 3010097171
- 1018470
- 3008262872
- 1064858
- 3010363503
- 3010531069
- 3008556682
- 9616671
- 8043792
- 1057425
- 1818910
- 1000547811
- 1836357
- 3000264985
- 3014833750
- 3009475821
- 3005913274
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | 2026-05-19 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | 2026-02-04 |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026-01-28 |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 |
| K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025-11-12 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025-06-06 |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025-06-05 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025-01-22 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 |
Legacy Summary#
summary
FDA Review#
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