# K023647: Cadence Peek Cemeent Restrictor

- Pathway: 510(k) (Special)
- Applicant: Spinal Concepts, Inc.
- Decided: Nov 27, 2002 after 28 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K003718 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022218: Cadence Cement Restrictor, Spinal Concepts, Inc. (2002)

## Most influential descendants
- K031318: Traxis Cement Restrictor (2003), 1 descendant of its own
- K041583: Peek Cement Restrictor X-Box (2004), 0 descendants of its own

## Indications for use
The Cadence PEEK Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Source page: https://510kreport.com/device/K023647
Methodology: https://510kreport.com/methodology