# K030265: CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Mar 4, 2003 after 36 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960658 (1996). 1 ancestor in all.
10 later devices descend from it; 4 cite it directly.
0 of 12 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 1.

## Most influential descendants
- K060040: Zimmer M/L Taper Hip Prosthesis (2006), 3 descendants of its own
- K191735: CPT Hip System (2020), 2 descendants of its own
- K192660: Zimmer M/L Taper Hip Prosthesis (2020), 2 descendants of its own
- K152530: UCP Stem (2016), 2 descendants of its own
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-0843-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Jan 11, 2016 · Class II · Z-1120-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Oct 11, 2013 · Class II · Z-1032-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

## Indications for use
The CPTB 12/14 Hip Prostheses are indicated for use with 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 and in the presence of proximal femoral bone defects; 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 andor total hip components in the affected extremity; and patients with acute femoral neck fractures.

Source page: https://510kreport.com/device/K030265
Methodology: https://510kreport.com/methodology