# K062132: Avs PL Peek Spacer System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Aug 16, 2006 after 21 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). 20 ancestors in all.
243 later devices descend from it; 2 cite it directly.
0 of 264 devices in its family (counting itself) have 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.

## Most influential descendants
- K120345: Honour Spacer System (2012), 212 descendants of its own
- K171140: Matrixx System (2017), 145 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own

## Indications for use
The Stryker Spine AVS PL 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 PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Source page: https://510kreport.com/device/K062132
Methodology: https://510kreport.com/methodology