# K070978: Zimmer Segmental System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 3, 2007 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945028 (1996). 3 ancestors in all.
13 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)
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 1.
- K002324: Modified to Modular FR Severe Bone Loss Trauma, Sulzermedica (2000) Summary page 1.

## 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
- Aug 1, 2017 · Class II · Z-0721-2018: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
- Feb 28, 2017 · Class II · Z-2566-2017: 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.
- Feb 28, 2017 · Class II · Z-2574-2017: 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.
- Feb 28, 2017 · Class II · Z-2575-2017: 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.
- Dec 19, 2013 · Class II · Z-0783-2014: After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instru
- Dec 19, 2013 · Class II · Z-0784-2014: After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instru

## 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, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle - Valgus, varus or flexion deformities - The salvage of previously failed surgical attempts A total femoral replacement construct consisting of MOST Options proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement. * 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 and the remainder of the stem must also be cemented against the bone. * The TrabecularMetal collar may be used cemented or uncemented against the bone as long as the remainder of the stem extension is cemented. * All other constructs are for cemented use only.

Source page: https://510kreport.com/device/K070978
Methodology: https://510kreport.com/methodology