# K051205: Stryker Spine Avs Asl Peek Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Nov 4, 2005 after 177 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: 8 generations back to K003155 (2001). 26 ancestors in all.
829 later devices descend from it; 2 cite it directly.
1 of 856 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050624: Stryker Spine Avs PL Peek Spacer, Stryker Spine (2005) Summary page 1.
- K042571: Stryker Spine Avs TL Peek Spacer, Stryker Spine (2005) Summary page 1.
- K040731: Stryker Spine Vertebral Spacer, Stryker Spine (2004) Summary page 1.
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 1.
- K011037: Vertebral Spacer, Synthes (Usa) (2002)
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.

## Most influential descendants
- 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
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System (2009), 554 descendants of its own
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 descendants of its own
- K111122: Aesculap Sibd XP Spinal System (2011), 460 descendants of its own

## Indications for use
The Stryker Spine AVS Tm ASL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and 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 AVS Tm ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS Tm ASL PEEK Spacer include, but are not limited to, Stryker Spine plate rod or rod systems (XIA, Spiral Radius 90D, and Trio).

Source page: https://510kreport.com/device/K051205
Methodology: https://510kreport.com/methodology