# K222912: c1Trac

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: May 16, 2023 after 232 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894435 (1989). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151640: Eltrac 471, Enraf-Nonius, B.V. (2015) Summary page 4.

## Indications for use
clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

Source page: https://510kreport.com/device/K222912
Methodology: https://510kreport.com/methodology