Velora Acetabular System
FDA 510(k) K252067 · Restor3D, Inc.
510(k) numberK252067
Submission
- Device name
- Velora Acetabular System
- Applicant
- Restor3D, Inc.
Durham, NC, US - Received
- July 1, 2025
- Decision date
- December 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
| K251718 | ArTT Augments and Buttresses and Bone ScrewsLPH · Traditional | Lima Corporate S.P.A. | 08/29/2025SE |
More from Lima Corporate S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | 07/01/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | 05/07/2026SE |
| K252454 | Kinos Total Ankle SystemHSN · Special | 09/03/2025SE |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty SystemPHX · Traditional | 05/19/2025SE |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement SystemMBH · Traditional | 03/27/2025SE |
| K242356 | TIDAL Fusion Cage SystemSAI · Traditional | 03/24/2025SE |
| K242868 | Kinos Total Ankle SystemHSN · Special | 10/18/2024SE |
| K241482 | Kinos Total Ankle SystemHSN · Traditional | 07/22/2024SE |
| K240591 | restor3d Kinos Axiom Total Ankle SystemHSN · Traditional | 04/29/2024SE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion SystemMAX · Special | 01/22/2024SE |
Questions and answers
When was Velora Acetabular System cleared by the FDA?
Velora Acetabular System (K252067) received a 510(k) decision of Substantially Equivalent on December 5, 2025, 157 days after the submission was received.
What is the product code of K252067?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.