# K101296: Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 30, 2010 after 81 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 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
- 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
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own

## Recalls of this device
- Mar 29, 2018 · Class II · Z-1381-2018: There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
- Feb 5, 2015 · Class II · Z-1219-2015: PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

Source page: https://510kreport.com/device/K101296
Methodology: https://510kreport.com/methodology