# K123180: Falcon Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jan 8, 2013 after 90 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 21 ancestors in all.
147 later devices descend from it; 1 cites it directly.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.
- K102313: Patriot Transcontinental M Spacers, Globus Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K131276: Lateral Synfix (2014), 146 descendants of its own
- K150673: SYNFIX Evolution Secured Spacer System (2015), 137 descendants of its own
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (2016), 127 descendants of its own
- K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology (2017), 109 descendants of its own
- K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (2019), 108 descendants of its own

## Indications for use
The Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenotis bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Falcon Spacer is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K123180
Methodology: https://510kreport.com/methodology