# K223348: My3D® Personalized Pelvic Reconstruction

- Pathway: 510(k) (Traditional)
- Applicant: Onkos Surgical, Inc.
- Decided: Jan 30, 2023 after 89 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983035 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212815: My3D® Personalized Pelvic Reconstruction, Onkos Surgical (2022) Summary page 5.

## Recalls of this device
- Jul 24, 2026 · Class II · Z-0091-2027: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
- Jul 24, 2026 · Class II · Z-0090-2027: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

## Indications for use
The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant. The pelvic implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

Source page: https://510kreport.com/device/K223348
Methodology: https://510kreport.com/methodology