# K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 1, 2011 after 88 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: 3 generations back to K945028 (1996). 6 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 17 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 2.
- K101296: Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions, Zimmer, Inc. (2010) Summary page 2.
- K964350: Modula Options for Severe Bone Loss and Trauma, Intermedics Orthopedics (1997) Summary page 2.
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K001303: Breast Immobilization Device MR-by 160, Mri Devices Corp. (2000). Our reading of the summary gave K001303, FDA’s number for Breast Immobilization Device MR-by 160 (Mri Devices Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MOST Options System”. Kept off the family tree.

## Most influential descendants
- 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
- K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (2026), 0 descendants of its own

## 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, osteoarthritis, traumatic arthritis, polyartliritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia. - Valgus, yamus or flexion deformities - The salvage of previously failed surgical attempts A total femoral replacement construct consisting of the MOST Options@ or Segmental proximal femoral, 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 TrabecularMetal 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 TrabecularMetal 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 TrabecularMetal collar may be used cemented or uncemented against the bone. All other constructs are for cemented use only.

Source page: https://510kreport.com/device/K110940
Methodology: https://510kreport.com/methodology