# K113122: Pipeline CR Primary Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Orthopedics
- Decided: Mar 20, 2012 after 151 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: 2 generations back to K933785 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 2.

## Cited in the summary but kept off the family tree
- K072726: Gender Solutions Natural-Knee Flex System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K123692: Pipeline Knee System (2013), 0 descendants of its own

## Indications for use
The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing 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 prior 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. Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K113122
Methodology: https://510kreport.com/methodology