# K221332: OsteoCentric Spine MIS Pedicle Fastener System

- Pathway: 510(k) (Traditional)
- Applicant: OsteoCentric Technologies
- Decided: Jul 28, 2022 after 80 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: 16 generations back to K853033 (1985). 232 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151648: Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System, Altus Partners, LLC (2015) Summary page 4.
- K132280: Altus Spine Pedicle Screw System, Altus Partners (2013) Summary page 4.

## Most influential descendants
- K250520: OsteoCentric Navigated Instruments System (2025), 0 descendants of its own

## Indications for use
The OsteoCentric Spine MIS Pedicle Fastener System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The OsteoCentric Spine MIS Pedicle Fastener System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain ofdiscogenic origins with degeneration ofthe disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the OsteoCentric Spine MIS Pedicle Fastener System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain ofdiscogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K221332
Methodology: https://510kreport.com/methodology