510(k) K991485
- Device
- SYNERGY POROUS SIZE 8 HIP STEM
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K991485
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-07-12
- Date received
- 1999-04-28
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID HENLEY
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 3016778562
- 1835251
- 8010916
- 3006536454
- 3013055499
- 3021008900
- 3010576282
- 3005360851
- 3016438694
- 3008668801
- 3004638532
- 3013557690
- 9681465
- 3014763043
- 1450662
- 3026776
- 3014273644
- 2030624
- 3000264985
- 3010057495
- 1226188
- 3006801265
- 3003387384
- 3014315560
- 3036773273
- 3014252644
- 3007334927
- 9681642
- 3008868758
- 3005751028
- 1061927
- 3010039400
- 2134285
- 3003639920
- 3006356043
- 2249615
- 1833920
- 3001278222
- 3011015572
- 3013014058
- 3020162561
- 1643817
- 3024890263
- 1221053
- 3005581234
- 3008544874
- 3004641308
- 3002808022
- 1225675
- 8010379
- 3002807090
- 3013176080
- 3004371426
- 3007353762
- 3031800723
- 1057425
- 1054811
- 3010009693
- 1835444
- 3012392319
- 1529009
- 1836357
- 3012275107
- 3012130008
- 3002806470
- 8043792
- 3038503932
- 8044172
- 3010041993
- 3009959868
- 1834331
- 3005061536
- 3004153240
- 9613350
- 3010388970
- 3012725451
- 1000547811
- 3010120135
- 3009973505
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261453 | G7® Acetabular System | Zimmer Biomet | 2026-09-23 |
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026-08-28 |
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | 2026-06-05 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases