# K945115: Mallory-Head Modular Calcar Repacement Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 2, 1995 after 196 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
537 later devices descend from it; 4 cite it directly.
0 of 538 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974558: Salvage/Onocology Hip and Total Femur System (1998), 508 descendants of its own
- K032396: Ringloc 36MM Line and Modular Femoral Heads (2003), 505 descendants of its own
- K042051: Arcomxl Polyethylene Liners (2005), 355 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0622-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Source page: https://510kreport.com/device/K945115
Methodology: https://510kreport.com/methodology