# K033837: Stryker Spine Vertebral Body Support System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 8, 2004 after 29 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
No predicates in its family tree.
896 later devices descend from it; 1 cites it directly.
2 of 897 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Surgical Dynamics Mesh Cage System: named in the summary without a submission number

## Most influential descendants
- K040731: Stryker Spine Vertebral Spacer (2004), 895 descendants of its own
- K042571: Stryker Spine Avs TL Peek Spacer (2005), 894 descendants of its own
- K050624: Stryker Spine Avs PL Peek Spacer (2005), 892 descendants of its own
- K051205: Stryker Spine Avs Asl Peek Spacer (2005), 829 descendants of its own
- K060762: Aesculap Peek Vertebral Body Replacement System (2006), 789 descendants of its own

## Indications for use
The Stryker Spine Vertebral Body Support System implant is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (Ti-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra due to tumor or trauma (i.e. fracture). For both corpectomy and vertebrectomy procedures, the Stryker Spine Vertebral Body Support System is intended to be used with supplemental internal spinal fixation systems. The use of bone graft with the Stryker Spine Vertebral Body Support System is optional.

Source page: https://510kreport.com/device/K033837
Methodology: https://510kreport.com/methodology