# K240233: Pitkar Spinal Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: S.H.Pitkar Orthotools Pvt., Ltd.
- Decided: Sep 9, 2024 after 224 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 17 generations back to K990745 (1999). 208 ancestors in all.
No later device cites it as a predicate yet.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043578: The 4CIS Spinal System and 4CIS Low Back System, Solco Biomedical Co., Ltd. (2005) Summary page 5.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 5.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 5.
- K190471: 4CIS® Chiron Spinal Fixation System, Solco Biomedical Co., Ltd. (2019) Summary page 5.
- K180226: TREND II Spinal Fixation System- STEP Series, Paonan Biotech Co., Ltd. (2018) Summary page 5.
- K201457: Auxein Brand Vertaux 5.5 mm Pedicle Screw System, Auxein Medical Private Limited/71164 (2021) Summary page 5.

## Indications for use
The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion

Source page: https://510kreport.com/device/K240233
Methodology: https://510kreport.com/methodology