# K060040: Zimmer M/L Taper Hip Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: May 12, 2006 after 126 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850055 (1985). 22 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032726: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Zimmer, Inc. (2003) Summary page 1.
- K042337: Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating, Zimmer, Inc. (2004) Summary page 1.
- K030265: CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00, Zimmer, Inc. (2003) Summary page 1.
- K973714: Versys Hip System Beaded Hip Prosthesis, Zimmer, Inc. (1997) Summary page 1.

## Most influential descendants
- K192660: Zimmer M/L Taper Hip Prosthesis (2020), 2 descendants of its own
- 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

## Recalls of this device
- May 30, 2018 · Class II · Z-2361-2018: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the po
- Mar 1, 2018 · Class II · Z-1192-2018: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.

## Indications for use
Total hip replacement for the following: 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, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: 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.

Source page: https://510kreport.com/device/K060040
Methodology: https://510kreport.com/methodology