# K080108: Cortoss Bone Augmentation Material

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Jun 5, 2009 after 507 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K970097 (1997). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.
- K043593: Spine-Fix Biomimetic Bone Cement, Teknimed, S.A. (2006) Summary page 1.
- K053336: Staxx FX System, Spine Wave, Inc. (2006) Summary page 1.
- K063606: Modification to Staxx FX System, Spine Wave, Inc. (2007) Summary page 1.
- K060300: Confidence High Viscosity Bone Cement, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 1.

## Recalls of this device
- May 18, 2021 · Class II · Z-2101-2021: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
- May 18, 2021 · Class II · Z-2100-2021: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
- Apr 1, 2020 · Class II · Z-1900-2020: Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
- Mar 31, 2011 · Not classified · Z-3188-2011: Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause

## Indications for use
CORTOSS ® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K080108
Methodology: https://510kreport.com/methodology