# K202730: Quadra-P

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Dec 28, 2020 after 101 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935452 (1994). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181254: Quadra P, Medacta International S.A. (2018) Summary page 4.
- K192827: Quadra-P, Medacta International S.A. (2020) Summary page 4.

## Most influential descendants
- K250450: Coated hip implants (2025), 0 descendants of its own

## Indications for use
The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia • Avascular necrosis of the femoral head • Acute traumatic fracture of the femoral head or neck • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

Source page: https://510kreport.com/device/K202730
Methodology: https://510kreport.com/methodology