# K250092: HC Biologics Osteopoint Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: HC Biologics, LLC
- Decided: Mar 27, 2025 after 72 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: 7 generations back to K950697 (1995). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241657: MSFX Mikron Spinal Fixation System, Mikron Makina Sanayi VE Ticaret Ltd. Sti. (2024) Summary page 5.

## Indications for use
The HC Biologics Osteopoint Spinal Fixation System is intended 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 sacral spine: -Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), -Spondylolisthesis, -Trauma (i.e., fracture or dislocation), -Spinal stenosis, -Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), -Tumor, -Pseudoarthrosis, and/or -Failed previous fusion

Source page: https://510kreport.com/device/K250092
Methodology: https://510kreport.com/methodology