# K252067: Velora Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D, Inc.
- Decided: Dec 5, 2025 after 157 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K941847 (1994). 395 ancestors in all.
No later device cites it as a predicate yet.
0 of 395 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190904: Conformis BeneFIT Hip System, Conformis, Inc. (2019) Summary page 5.
- K243977: EMPHASYS Acetabular System, Depuy Ireland UC (2025) Summary page 5.
- K190660: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene, Zimmer, Inc. (2019) Summary page 5.

## Indications for use
The Velora Acetabular System is indicated for use in skeletally mature individuals undergoing total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia. • Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. • Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The implants in the Velora Acetabular System are intended for cementless fixation using an anterior or posterior surgical approach.

Source page: https://510kreport.com/device/K252067
Methodology: https://510kreport.com/methodology