# K032726: Zimmer M/L Taper Hip Prosthesis, 7711 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 22, 2003 after 49 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 4 generations back to K850055 (1985). 14 ancestors in all.
84 later devices descend from it; 7 cite it directly.
1 of 99 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.
- K020963: Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K994286: ZMR Hip System-Porous Revision, Zimmer, Inc. (2000) Summary page 1.
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis, Zimmer, Inc. (1997) Summary page 1.

## Most influential descendants
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K130899: Biolox Delta Ceramic Femoral Heads (2013), 19 descendants of its own
- K120030: Taperloc Complete Size 4MM and XR 123 (2012), 14 descendants of its own

## Recalls of this device
- Mar 1, 2018 · Class II · Z-1191-2018: 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.
- Feb 11, 2016 · Class II · Z-1046-2016: Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etch
- May 23, 2014 · Class II · Z-2033-2014: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

## 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/K032726
Methodology: https://510kreport.com/methodology
