# K062083: Synfix -LR

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Apr 3, 2007 after 256 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: 1 generation back to K010530 (2001). 2 ancestors in all.
1,252 later devices descend from it; 6 cite it directly.
1 of 1,255 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011037: Vertebral Spacer, Synthes (Usa) (2002) Summary page 1.
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K072253: Synfix-LR Spacer (2007), 1,250 descendants of its own
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX (2008), 1,102 descendants of its own
- K080758: Avs PL Peek Spacers, Models 48351 and 48353 (2008), 1,091 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own

## Indications for use
The SynFix-LR is a stand-alone vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial vertebrectomy procedures for the treatment of tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues. The interior of the spacer component of the SynFix-LR can be packed with bone (autograft or allografi). The SynFix-LR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K062083
Methodology: https://510kreport.com/methodology