# K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 13, 1997 after 78 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850055 (1985). 6 ancestors in all.
363 later devices descend from it; 7 cite it directly.
1 of 370 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901687: F-24 Femoral Hip Prosthesis, Med-Tek Corp. (1990) Summary page 1.
- K921308: HG Multilock Hip Prosthesis W/ TI-Nidium, Zimmer, Inc. (1994) Summary page 1.
- K922071: Zimmer Anatomic Hip System, Zimmer, Inc. (1994) Summary page 1.
- K961378: Delta Hip Prosthesis, Zimmer, Inc. (1996) Summary page 1.

## Most influential descendants
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series (2003), 296 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K043079: Bicontact Hip System with U-Cap (2004), 166 descendants of its own
- K093472: Trinity Acetabular System (2010), 117 descendants of its own

## Indications for use
The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following: - Total Hip Replacement: 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: 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/K964769
Methodology: https://510kreport.com/methodology