510(k) K161569
- Device
- Trident® II Tritanium® Acetabular Shells And 6.5 Mm Low Profile Hex Screws
- Applicant
- Howmedica Osteonics Corp. Aka Stryker Orthopaedics
- 510(k) number
- K161569
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-10-14
- Date received
- 2016-06-07
- 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
- Valerie Giambanco
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3009888740
- 3010576282
- 3014315560
- 3000236920
- 3010057495
- 1721676
- 3004635447
- 3013302242
- 3006946276
- 3010047454
- 3000264985
- 8044172
- 3013791180
- 9681465
- 1833986
- 3002806535
- 3010041693
- 2242737
- 1226544
- 3005562917
- 3004188066
- 3006085220
- 1834331
- 1218882
- 3009475821
- 3010178296
- 3003761012
- 3015398319
- 3008021110
- 3005718816
- 3010375065
- 8010916
- 8010379
- 1645151
- 3022142628
- 3004153240
- 3009973336
- 3003477135
- 3012329926
- 3002807112
- 3014302784
- 3014273644
- 3025603301
- 3005913274
- 3008262872
- 3006395932
- 9613369
- 1526534
- 3010163695
- 3020967480
- 1649518
- 3008668801
- 3014763043
- 3002808022
- 3007334927
- 3012425419
- 2528981
- 3006536454
- 3007189546
- 3007200272
- 3012119238
- 3008572101
- 3017410889
- 3013055499
- 3031800723
- 3005852519
- 3002806603
- 3004641308
- 3002807314
- 1000550978
- 1835572
- 3010132111
- 3011274144
- 1047843
- 3038503932
- 2249697
- 3010039400
- 3010386387
- 3011277306
Source Documents#
Other 510(k) Records For Product Code LPH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 |
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