# K120313: Neo CR Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Orthopedics
- Decided: Apr 20, 2012 after 79 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: 5 generations back to K933785 (1995). 13 ancestors in all.
3 later devices descend from it; 3 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)
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 2.
- K073286: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2008) Summary page 2.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 2.

## Most influential descendants
- K131368: Neo Knee System (2013), 1 descendant of its own
- K122500: Neo PS Knee System (2013), 1 descendant of its own
- K142388: Neo Total Knee System (2014), 0 descendants of its own

## Indications for use
The NEO CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral 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. Neo CR Knee System components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K120313
Methodology: https://510kreport.com/methodology