# K192798: Zimmer Segmental System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 10, 2020 after 437 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945028 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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 5.
- K081860: Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments, Zimmer, Inc. (2008) Summary page 5.
- K101296: Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions, Zimmer, Inc. (2010) Summary page 5.
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen, Zimmer, Inc. (2011) Summary page 5.
- K150028: Zimmer Segmental System XT Components, Zimmer, Inc. (2015) Summary page 5.
- K183136: Zimmer Segmental System Proximal Femoral Component, Zimmer, Inc. (2019) Summary page 5.

## Indications for use
This device is indicated for: - Moderate to severe knee instability - Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, ostcoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia - Valgus, varus or flexion deformities - The salvage of previously failed surgical attempts * A total femoral replacement construct consisting of Segmental proximal fernoral, Segmental System segments and Segmental System distal femoral components may be used without cement. * Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented. * Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone. * The Trabecular Metal collar may be used cemented or uncemented against the bone. * All other constructs are for cemented use only.

Source page: https://510kreport.com/device/K192798
Methodology: https://510kreport.com/methodology