# K120564: Calypso System

- Pathway: 510(k) (Traditional)
- Applicant: Hogan Lovells US LLP
- Decided: Jul 16, 2012 after 143 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K040583 (2004). 128 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100623: Aesculap Implant Systems S4 Spinal System, Aesculap Implant Systems (2010) Summary page 1.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 1.

## Most influential descendants
- K132303: Implanet Spine System (2013), 15 descendants of its own
- K143731: IMPLANET Spine System (ISS) (2015), 8 descendants of its own
- K162764: Jazz Frame System (2017), 6 descendants of its own
- K182771: ISS-JAZZ Screw System and JAZZ CAP SP (2019), 5 descendants of its own
- K170730: JAZZ System, including JAZZ Band (2017), 5 descendants of its own

## Indications for use
The Implanet Calypso System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedlicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.

Source page: https://510kreport.com/device/K120564
Methodology: https://510kreport.com/methodology