# K120538: Palls M Spinal System

- Pathway: 510(k) (Special)
- Applicant: Korea Bone Bank Co., Ltd.
- Decided: Mar 23, 2012 after 30 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 6 generations back to K000319 (2000). 11 ancestors in all.
1 later device descends 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)
- K102574: Palla M Spinal System, Korea Bone Bank Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K140359: Maximis Spinal Fixation System (2015), 0 descendants of its own

## Indications for use
The Pallas M Spinal System is intended for posterior, noncervical pedlicle 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, kypbosis, spinal tumor and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K120538
Methodology: https://510kreport.com/methodology