# K973714: Versys Hip System Beaded Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 24, 1997 after 86 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931641 (1994). 3 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953337: Beta Hip Prosthesis, Zimmer, Inc. (1996) Summary page 2.
- P820024: Prosthesis, Hip, Hemi-Femoral, Metal, Depuy, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P820024/S001 (Mar 16, 1984). Summary page 2.
- K931641: Porocoat Porous Coating, Depuy, Inc. (1994) Summary page 2.

## Most influential descendants
- K042776: Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XX (2004), 11 descendants of its own
- 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

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1026-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1023-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1025-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1022-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1024-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Aug 1, 2017 · Class II · Z-0722-2018: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
- Jan 11, 2016 · Class II · Z-0848-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- May 19, 2014 · Class II · Z-1842-2014: During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05

## Indications for use
The VerSys Beaded 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 endoprotheses 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 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/K973714
Methodology: https://510kreport.com/methodology