# K181921: Solidity Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA
- Decided: Nov 16, 2018 after 121 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: 21 generations back to K841189 (1984). 201 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 204 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012254: VBR, Osteotech, Inc. (2001) Summary page 4.
- K003155: Vertebral Body Replacement, Osteotech, Inc. (2001) Summary page 4.
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System, Choicespine (2017) Summary page 4.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 4.
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 4.

## Most influential descendants
- K200235: KONG-TL VBR System, KONG-C VBR System (2020), 1 descendant of its own
- K232790: KONG®-TL VBR System and KONG® C VBR System (2024), 0 descendants of its own

## Indications for use
The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.

Source page: https://510kreport.com/device/K181921
Methodology: https://510kreport.com/methodology