# K102574: Palla M Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Korea Bone Bank Co., Ltd.
- Decided: Mar 7, 2011 after 180 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 5 generations back to K000319 (2000). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082509: Eos Spinal System, Korea Bone Bank Co., Ltd. (2008) Summary page 2.
- K053573: GSS Pedicle Screw System, GS Medical Co., Ltd. (2006)

## Most influential descendants
- K120538: Palls M Spinal System (2012), 1 descendant of its own
- K140359: Maximis Spinal Fixation System (2015), 0 descendants of its own

## Indications for use
The Pallas M Spinal system is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K102574
Methodology: https://510kreport.com/methodology