# K131368: Neo Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Orthopedics
- Decided: Oct 3, 2013 after 143 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933785 (1995). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120313: Neo CR Knee System, Pipeline Orthopedics (2012) Summary page 1.
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 2.

## Cited in the summary but kept off the family tree
- K114821: Journey II Deep Dished Articular Inserts. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K142388: Neo Total Knee System (2014), 0 descendants of its own

## Indications for use
The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to: * Osteoarthritis, rheumatoid arthritis, past-traumatic arthritis, moderate deformities and femnoral condyle osteonecrosis. * Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result. * Post-traumatic loss of joint configuration, particularly when there Is patellofemoral erosion, dysfunction or prior patellectomy. * Moderate valgus, varus, or flexion deformities. The Neo Total Knee System components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K131368
Methodology: https://510kreport.com/methodology