# K181995: Chiral Surgical Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Chiral Surgical
- Decided: Sep 20, 2018 after 56 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: 6 generations back to K040583 (2004). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121615: 4CIS Vane Spine System, Solco Biomedical Co., Ltd. (2012) Summary page 5.
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System, Cross Medical Products, Inc. (1998) Summary page 5.
- K103049: TSRH Spinal System, Medtronic Sofamor Danek (2010) Summary page 5.

## Indications for use
The Chiral Surgical Pedicle Screw System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

Source page: https://510kreport.com/device/K181995
Methodology: https://510kreport.com/methodology