# K191735: CPT Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 20, 2020 after 266 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960658 (1996). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960658: Collarless Polished Taper Hip Prosthesis, Zimmer, Inc. (1996) Summary page 5.
- K030265: CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00, Zimmer, Inc. (2003) Summary page 5.

## Most influential descendants
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own

## Indications for use
The CPT Hip System is indicated for cemented use in: – Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. – Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. – Patients suffering from disability due to previous fusion. – Patients with previously failed endoprostheses and/or total hip components in the affected extremity. – Patients with acute femoral neck fractures.

Source page: https://510kreport.com/device/K191735
Methodology: https://510kreport.com/methodology