# K053276: Ist Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Spinal Technologies, Inc.
- Decided: Dec 27, 2005 after 34 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
No predicates in its family tree.
69 later devices descend from it; 4 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122571: Malibu Spinal System with the Daytona Deformity System (2012), 62 descendants of its own
- K160902: Mariner Pedicle Screw System (2016), 60 descendants of its own
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own
- K211606: Mariner Deformity System (2021), 47 descendants of its own

## Indications for use
Open or percutaneous approach: When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K053276
Methodology: https://510kreport.com/methodology