# K042776: Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XX

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Nov 4, 2004 after 29 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931641 (1994). 4 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973714: Versys Hip System Beaded Hip Prosthesis, Zimmer, Inc. (1997) Summary page 1.

## Most influential descendants
- K061786: Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis (2006), 10 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K210678: implaFit® hip stems (2022), 3 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-0846-2016: LDPE bag containing the implant adheres to the highly polished implant surface.

## Indications for use
The VerSys Beaded MidCoat Low Head Center Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for: 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. Hremi-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 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/K042776
Methodology: https://510kreport.com/methodology