# K123692: Pipeline Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Orthopedics
- Decided: May 24, 2013 after 172 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: 12 generations back to K810258 (1981). 193 ancestors in all.
No later device cites it as a predicate yet.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113122: Pipeline CR Primary Knee System, Pipeline Orthopedics (2012) Summary page 1.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 2.
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 2.
- K121443: Journey II CR Knee System, Smith & Nephew, Inc. (2012) Summary page 2.
- K111711: Journey II BCS Knee System, Smith & Nephew, Inc. (2011) Summary page 2.
- K113369: Zimmer Persona Knee System, Zimmer, Inc. (2012) Summary page 2.
- K111481: Corin Trinity Acetabular System Ecima Liners, Corin USA (2012) Summary page 2.
- K040770: Vanguard Patella Components, Biomet Manufacturing, Inc. (2004) Summary page 2.
- K122870: Itotal Cruciate Retaining (CR) Knee Replacement System, Conformis, Inc. (2013). Cleared while this submission was under review Summary page 2.
- (no number) CR Knee System: named in the summary without a submission number
- (no number) BCS Knee System: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K000235: Insyte Catheter, Insyte Autoguard Catheter, Becton Dickinson Infusion Therapy Systems, Inc. (2000). Our reading of the summary gave K000235, FDA’s number for Insyte Catheter, Insyte Autoguard Catheter (Becton Dickinson Infusion Therapy Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Natural Knee II Durasul Tibial Insert and Patella”. Kept off the family tree.

## Indications for use
The Pipeline Knee System is indicated for skeletally mature patients with severe knee pain and disability due to: * Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, * Collagen disorders, and/or avascular necrosis of the femoral condyle, * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, * Moderate valgus, varus, or flexion deformities, * The salvage of previously tailed surgical attempts or for a knee in which satisfactory stability in flexion cannot otherwise be obtained at the time of surgery.. Pipeline Knee System components are indicated for use only with cement, and are single use devices.

Source page: https://510kreport.com/device/K123692
Methodology: https://510kreport.com/methodology