# K060300: Confidence High Viscosity Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Jun 21, 2006 after 135 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002652 (2001). 5 ancestors in all.
176 later devices descend from it; 7 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 2.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 2.
- K042691: Vertefix Vertebroplasty Procedure Set, Cook, Inc. (2005) Summary page 2.

## Most influential descendants
- K102397: Kyphon Xpede Bone Cement (2011), 165 descendants of its own
- K150460: KYPHON (R) HV-R (R) Bone Cement (2015), 162 descendants of its own
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (2016), 159 descendants of its own
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (2016), 106 descendants of its own
- K170347: CD HORIZON™ Fenestrated Screw Set (2017), 91 descendants of its own

## Recalls of this device
- Dec 15, 2017 · Class II · Z-1300-2018: Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
- Apr 17, 2013 · Class II · Z-2132-2013: During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
- Apr 17, 2013 · Class II · Z-2133-2013: During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
- Apr 17, 2013 · Class II · Z-2134-2013: During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
- Jan 15, 2013 · Class II · Z-0960-2013: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
- Jan 15, 2013 · Class II · Z-0962-2013: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
- Jan 15, 2013 · Class II · Z-0961-2013: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
- Jan 15, 2013 · Class II · Z-0963-2013: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

## Indications for use
The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Source page: https://510kreport.com/device/K060300
Methodology: https://510kreport.com/methodology