# K110153: SFC Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Konigsee Implantate GmbH
- Decided: Oct 12, 2011 after 266 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K841189 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091743: Sec VBR, Innvotec Surgical, Inc. (2009) Summary page 1.
- K083186: Aesculap Hydrolift VBR System, Aesculap Implant System, Inc. (2010) Summary page 1.
- K061891: Synex II, Synthes Spine Co.Lp (2006) Summary page 1.

## Indications for use
SFC™ has been designed to be used in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFC™ is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFC™ may be used with autograft or allograft.

Source page: https://510kreport.com/device/K110153
Methodology: https://510kreport.com/methodology