# K051491: Trabecular Metal Primary Hip Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Jun 30, 2005 after 24 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850055 (1985). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis, Zimmer, Inc. (1997) Summary page 1.

## 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

## Recalls of this device
- Jan 3, 2018 · Class II · Z-0939-2018: Two lots of hip implants are mislabeled.
- Nov 16, 2011 · Not classified · Z-0366-2012: Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off durin
- Aug 2, 2006 · Not classified · Z-1471-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1473-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1472-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

## 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/K051491
Methodology: https://510kreport.com/methodology