# K043355: Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X

- Pathway: 510(k) (Special)
- Applicant: Sintea Biotech, Inc.
- Decided: Dec 17, 2004 after 11 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010515 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020085: Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X, Sintea Biotech, Inc. (2002) Summary page 1.
- K031893: Xia Spinal System and Xia Stainless Steel System, Howmedica Osteonics Corp. (2003) Summary page 1.

## Most influential descendants
- K081631: Sintea Biotech PLS Multi-Axial Screws (2008), 1 descendant of its own
- K112611: Sintea Plustek PLS Multi-Axial Screws (2012), 0 descendants of its own

## Indications for use
The Sintea Posterior Lumbar System 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 Sintea Biotech 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 tumor, and failed previous fusion (pseudarthrosis). The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl 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/K043355
Methodology: https://510kreport.com/methodology