# K053508: Synfix-LR

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Feb 13, 2006 after 59 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: 8 generations back to K003155 (2001). 21 ancestors in all.
39 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011037: Vertebral Spacer, Synthes (Usa) (2002) Summary page 1.
- K050624: Stryker Spine Avs PL Peek Spacer, Stryker Spine (2005) Summary page 1.

## Most influential descendants
- K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage (2011), 38 descendants of its own
- K120063: Venus Lumbar Intervertebral Body Fusion Cage System (2012), 37 descendants of its own
- K121096: Venus Lumbar Intervertebral Body Fusion Cage System (2012), 36 descendants of its own
- K151140: LnK Lumbar Interbody Fusion Cage System (2015), 29 descendants of its own
- K181380: LnK Lumbar Interbody Fusion Cage System (2018), 10 descendants of its own

## Recalls of this device
- Jul 23, 2010 · Not classified · Z-2583-2010: A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.

## Indications for use
The SynFixTM-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma (i.e., fracture). The SynFix TM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer component of the SynFixTm-LR can be packed with bone (autograft or allograft). SynFix TM-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K053508
Methodology: https://510kreport.com/methodology