# K112611: Sintea Plustek PLS Multi-Axial Screws

- Pathway: 510(k) (Special)
- Applicant: Sintea Plastek, LLC
- Decided: Apr 25, 2012 after 231 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: 4 generations back to K010515 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081631: Sintea Biotech PLS Multi-Axial Screws, Sintea Biotech, Inc. (2008) Summary page 1.

## Indications for use
The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion. The Posterior Lumbar System is a pedicle screw system intended 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 tumfor, and failed previous fusion (pseudarthrosis). The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K112611
Methodology: https://510kreport.com/methodology