# K182678: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 31, 2019 after 247 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: 8 generations back to K850055 (1985). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063251: Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology, Zimmer, Inc. (2007) Summary page 4.
- K071856: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks), 7713 Series, Zimmer, Inc. (2007) Summary page 4.
- K081007: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Zimmer, Inc. (2008) Summary page 4.

## Most influential descendants
- K200959: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling (2020), 0 descendants of its own

## Indications for use
• Total hip replacement for patients with: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. • Hemi-hip replacement for patients with: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. • The femoral stem is for cementless use only.

Source page: https://510kreport.com/device/K182678
Methodology: https://510kreport.com/methodology