# K181254: Quadra P

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 22, 2018 after 164 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: 9 generations back to K935452 (1994). 72 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173794: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, Medacta International S.A. (2018) Summary page 4.
- K082792: Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems, Medacta International S.A. (2008) Summary page 4.

## Most influential descendants
- K192827: Quadra-P (2020), 6 descendants of its own
- 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

## Indications for use
The hip prosthesis QUADRA-P is designed for cementless use in total or partial hip arthroplasty; for 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/K181254
Methodology: https://510kreport.com/methodology