# K250637: VCFix Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Amber Implants
- Decided: May 30, 2025 after 88 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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 K040583 (2004). 182 ancestors in all.
No later device cites it as a predicate yet.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223294: SpineJack® Expansion Kit, Stryker Instruments (2022) Summary page 6.

## Indications for use
The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.

Source page: https://510kreport.com/device/K250637
Methodology: https://510kreport.com/methodology