510(k) K243977
- Device
- EMPHASYS Acetabular System
- Applicant
- Depuy Ireland UC
- 510(k) number
- K243977
- Product code
- LPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-22
- Date received
- 2024-12-23
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Amy Joyce
- Address
- Loughbeg Ringaskiddy Cork IE
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3002807090
- 3027484613
- 3004641308
- 2242737
- 3005180920
- 3000236920
- 2133928
- 3007913880
- 1000547811
- 3009241418
- 3006085220
- 3013176080
- 3002807315
- 3017410889
- 3021008900
- 3007334927
- 3010386387
- 2134470
- 3010057495
- 3006801265
- 3014252644
- 3009871135
- 2183744
- 3016778562
- 3012275107
- 8044172
- 1644408
- 3023852420
- 1834331
- 3003541440
- 1226188
- 1018470
- 3010287737
- 3000264985
- 3013791180
- 3007420745
- 3005323511
- 1833920
- 1827096
- 3006809628
- 3002807112
- 3009760038
- 3020162561
- 3003595343
- 3025603301
- 3005061536
- 2032521
- 3010163695
- 3004142400
- 1643264
- 3006946279
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3009106092
- 3014763043
- 2648920
- 3007740680
- 3002806535
- 1721676
- 3015516266
- 3005581234
- 3009475821
- 3010041693
- 3006395932
- 1218882
- 3004635447
- 1064858
- 3002807314
- 9611390
- 3004153896
- 3013302242
- 3007923096
- 3010041993
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code LPH
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|---|---|---|---|
| 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 |
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| K252846 | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
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| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 |
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| K243456 | ONVOY Acetabular System | Globus Medical, Inc. | 2025-06-06 |
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| 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 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024-11-08 |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024-10-11 |