# K142388: Neo Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: New Era Orthopedics, LLC
- Decided: Dec 5, 2014 after 100 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: 7 generations back to K933785 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 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 4.
- K122500: Neo PS Knee System, Pipeline Orthopedics (2013) Summary page 4.
- K131368: Neo Knee System, Pipeline Orthopedics (2013) Summary page 4.

## 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: x Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis. x 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. x Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. x Moderate valgus, varus, or flexion deformities. The cruciate retaining (CR) femur with CR tibial insert is for use when the posterior cruciate ligament (PCL) is intact. The CR femur with UC tibial inserts is for use when the PCL is sacrificed. The posteriorly stabilized (PS) femur with PS tibial insert is for use when the PCL is sacrificed. The NEO Total Knee System components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K142388
Methodology: https://510kreport.com/methodology