510(k) K243192
- Device
- iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
- Applicant
- Nextstep Arthopedix, LLC
- 510(k) number
- K243192
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-05
- Date received
- 2024-09-30
- 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
- N
Applicant Contact#
- Contact
- Garrett Spurgeon
- Address
- 1800 Triplett Blvd. Akron OH US 44306 44306
FDA Registration Numbers#
- 3007539489
- 3006536454
- 2242737
- 1836357
- 1828464
- 1526534
- 1818910
- 3002807314
- 3002806603
- 2528981
- 3003541440
- 1000517406
- 3012425419
- 3020162561
- 1721676
- 1720929
- 3011015572
- 3008421730
- 3010039400
- 1424263
- 3006128100
- 3004748528
- 3024890263
- 9614209
- 9681465
- 3003477135
- 3010531069
- 3007311878
- 3009973336
- 9611390
- 3004371426
- 9616671
- 1833986
- 3005551626
- 3002806470
- 3036773273
- 2249615
- 2648920
- 3014833750
- 3004635447
- 9616680
- 3033509898
- 1822565
- 3006946276
- 3014273644
- 1825034
- 3020155054
- 3043543260
- 3010388970
- 3010178296
- 1225675
- 9610726
- 1226188
- 1834379
- 3003595343
- 3007420745
- 3007740680
- 3004513872
- 1833920
- 3000258338
- 3009732568
- 3004153240
- 3007923096
- 1054811
- 1038671
- 3035366890
- 2183744
- 1000550978
- 3005751028
- 3008544874
- 1220477
- 3008556682
- 2134470
- 1057425
- 3015516266
- 3000264985
- 3014315560
- 3007200272
- 2245304
- 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 |