# K081860: Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 26, 2008 after 87 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945028 (1996). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070978: Zimmer Segmental System, Zimmer, Inc. (2007) Summary page 1.
- K960626: Modular Oncology System Technology (Most), Intermedics Orthopedics (1996) Summary page 1.
- K973087: Most Hex Intramedullary (I/M) Stem, Sulzer Orthopedics, Inc. (1997) Summary page 1.
- K003182: Orthogenesis LPS System, Depuy, Inc. (2001) Summary page 1.

## Most influential descendants
- K192798: Zimmer Segmental System (2020), 0 descendants of its own

## Recalls of this device
- Feb 28, 2017 · Class II · Z-2576-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

## Indications for use
General Indications for the Segmental System: * This device is indicated for: - Moderate to severe knee instability - Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle - Valgus, varus or flexion deformities - The salvage of previously failed surgical attempts Indications specific to the Variable Stiffness Stem extensions: Variable Stiffness stem extensions require the use of either a smooth or TrabecularMetal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone, but the remainder of the stem must be used uncemented.

Source page: https://510kreport.com/device/K081860
Methodology: https://510kreport.com/methodology