My3D® Personalized Pelvic Reconstruction
FDA 510(k) K212815 · Onkos Surgical
510(k) numberK212815
Submission
- Device name
- My3D® Personalized Pelvic Reconstruction
- Applicant
- Onkos Surgical
Parsippany, NJ, US - Received
- September 3, 2021
- Decision date
- July 6, 2022
- 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 |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| 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 |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage SystemQZZ · Traditional | 06/08/2026SE |
| K252920 | ELEOS Limb Salvage System with NanoCept® TechnologyQZZ · Special | 10/15/2025SE |
| K223348 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 01/30/2023SE |
| K211677 | ELEOS Limb Salvage SystemKRO · Traditional | 07/28/2021SE |
| K203815 | ELEOS Limb Salvage System with BioGripJDI · Traditional | 06/09/2021SE |
| K203588 | ELEOS Limb Salvage SystemJDI · Traditional | 02/05/2021SE |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIPJDI · Traditional | 12/11/2020SE |
| K180130 | ELEOS Bipolar Acetabular SystemKWY · Traditional | 02/23/2018SE |
| K161520 | ELEOS Limb Salvage SystemKRO · Traditional | 10/28/2016SE |
Questions and answers
When was My3D® Personalized Pelvic Reconstruction cleared by the FDA?
My3D® Personalized Pelvic Reconstruction (K212815) received a 510(k) decision of Substantially Equivalent on July 6, 2022, 306 days after the submission was received.
What is the product code of K212815?
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.