510(k) K143314
- Device
- Progressive Orthopaedic Total Hip System
- Applicant
- The Progressive Orthopaedic Company, LLC
- 510(k) number
- K143314
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-27
- Date received
- 2014-11-19
- 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
- SCOTT KEISER
- Address
- 801 Us Hwy. 1, Suite B North Palm Beach FL US 33408 33408
FDA Registration Numbers#
- 3008556682
- 3007200272
- 9610612
- 2648920
- 3040391045
- 3008868758
- 1822565
- 1057425
- 8043792
- 3014302784
- 3010287737
- 3014833750
- 3021008900
- 3006356043
- 1226544
- 1835572
- 3007366790
- 3008262872
- 3002806603
- 3006801265
- 1000547811
- 3019807891
- 3005180920
- 2244478
- 1644408
- 3006946276
- 3013302242
- 2134285
- 3012392319
- 3000196378
- 3030412764
- 3010155648
- 3003477135
- 3010065126
- 9613350
- 3006085220
- 3020155054
- 3008395353
- 3009871135
- 3033509898
- 2134470
- 3006017180
- 3009760038
- 3002807310
- 3010057495
- 3003998208
- 3004153240
- 3003761012
- 3009813841
- 2246552
- 3007740680
- 3009106092
- 3010388970
- 3017397663
- 3011189525
- 1833986
- 3011295718
- 3043543260
- 3010009693
- 3010375065
- 9611390
- 3009732568
- 3008658204
- 2531477
- 3006536454
- 3004188066
- 3002806470
- 3036756245
- 3031800723
- 3011015572
- 3013791180
- 3005360851
- 1018470
- 3003541440
- 8010379
- 3006395932
- 3048515471
- 3004638532
- 3010039400
- 3012275107
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#
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