# K040731: Stryker Spine Vertebral Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Aug 5, 2004 after 136 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: 5 generations back to K003155 (2001). 15 ancestors in all.
895 later devices descend from it; 3 cite it directly.
2 of 911 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033837: Stryker Spine Vertebral Body Support System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K033517: Spinal Concepts Inc. Cadence and Traxis, Spinal Concepts, Inc. (2004) Summary page 1.
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.

## Most influential descendants
- 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
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), 788 descendants of its own

## Indications for use
The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine Vertebral Spacer include, but are not limited to, Stryker Spine plate rod or rod systems (XIA, Spiral Radius gOD, and Trio).

Source page: https://510kreport.com/device/K040731
Methodology: https://510kreport.com/methodology