# K063251: Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 24, 2007 after 89 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 4 (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). 17 ancestors in all.
5 later devices descend from it; 4 cite it directly.
1 of 23 devices in its family (counting itself) has 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.
- K060358: Profemur TL Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 2.
- K042337: Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating, Zimmer, Inc. (2004) Summary page 2.

## Most influential descendants
- K081007: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System (2008), 3 descendants of its own
- K071856: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks), 7713 Series (2007), 3 descendants of its own
- K182678: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling (2019), 1 descendant of its own
- K200959: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling (2020), 0 descendants of its own
- K110836: CLS Brevius Stem with Kinectiv Technology (2011), 0 descendants of its own

## Recalls of this device
- May 30, 2018 · Class II · Z-2364-2018: 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
- May 30, 2018 · Class II · Z-2365-2018: 
- May 30, 2018 · Class II · Z-2375-2018: 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
- May 29, 2009 · Not classified · Z-1617-2009: The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

## 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. This femoral stem is for cementless use only.

Source page: https://510kreport.com/device/K063251
Methodology: https://510kreport.com/methodology