# K002324: Modified to Modular FR Severe Bone Loss Trauma

- Pathway: 510(k) (Special)
- Applicant: Sulzermedica
- Decided: Aug 24, 2000 after 24 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.
14 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070978: Zimmer Segmental System (2007), 13 descendants of its own
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen (2011), 10 descendants of its own
- K141331: Biomet Orthopaedic Salvage System (Oss) (2014), 3 descendants of its own
- K190100: USTAR II System (2019), 2 descendants of its own
- K183136: Zimmer Segmental System Proximal Femoral Component (2019), 1 descendant of its own

## Recalls of this device
- Nov 15, 2011 · Not classified · Z-0861-2012: Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site

Source page: https://510kreport.com/device/K002324
Methodology: https://510kreport.com/methodology