# K192827: Quadra-P

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 6, 2020 after 96 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: 10 generations back to K935452 (1994). 76 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 83 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.
- K083558: Medacta Total Hip Prosthesis System - Quadra C, Medacta International S.A. (2009) Summary page 4.

## Most influential descendants
- K202730: Quadra-P (2020), 1 descendant of its own
- K203041: SMS Cementless Stem (2020), 1 descendant of its own
- K250450: Coated hip implants (2025), 0 descendants of its own
- K251166: Mfinity Femoral System (2025), 0 descendants of its own
- K220405: Amis K Long (2022), 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/K192827
Methodology: https://510kreport.com/methodology