# K210842: VerSys Cemented Revision/Calcar

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 10, 2021 after 263 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913649 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913649: Modular Calcar Replacement, Zimmer, Inc. (1991) Summary page 4.

## Indications for use
VerSys Cemented Revision/Calcar is indicated for total hip arthroplasty in patients: Whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

Source page: https://510kreport.com/device/K210842
Methodology: https://510kreport.com/methodology