# K020085: Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.X

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Biotech, Inc.
- Decided: Dec 10, 2002 after 334 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: 1 generation back to K010515 (2001). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010720: TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2001)
- K010515: Modification to Synergy Spinal System, Interpore Cross Intl. (2001)

## Most influential descendants
- K043355: Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model PLS.01.T5.X (2004), 2 descendants of its own
- 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, fvacture, tumor, pseudoarthrosis, and failed previous fusion. The Sintea Biotech Posterior Lumbar System is apedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment ojthe 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 apedicle screw system indicatedfor the treatment ofsevere spondylolisthesis (Grades 3 and 4) of the L5-SI 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/K020085
Methodology: https://510kreport.com/methodology