# K090841: Addplus

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Oct 5, 2009 after 192 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: 2 generations back to K003155 (2001). 2 ancestors in all.
215 later devices descend from it; 1 cites it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012254: VBR, Osteotech, Inc. (2001) Summary page 1.

## Most influential descendants
- K121107: Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) (2012), 214 descendants of its own
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own
- K170157: INDEPENDENCE® Spacers (2017), 109 descendants of its own

## Indications for use
The AddPlusTM is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The AddPlusTM is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the AddPlusTM is optional.

Source page: https://510kreport.com/device/K090841
Methodology: https://510kreport.com/methodology