# K103320: Synthes XRL

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Oct 20, 2011 after 342 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K841189 (1984). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 1.
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 1.
- K041389: Synthes Contoured Synmesh Spacer, Synthes Spine (2004) Summary page 1.
- K050553: Novel VBR Spinal System, Alphatec/Nexmed (2005) Summary page 1.
- K062933: Synthes Oracle Spacer, Synthes Spine Co.Lp (2007) Summary page 1.

## 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
- K152460: Rectangular Corpectomy Cage (2015), 0 descendants of its own

## Recalls of this device
- Apr 8, 2014 · Class II · Z-1681-2014: Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

## Indications for use
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., LISS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft). The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K103320
Methodology: https://510kreport.com/methodology