# K122639: Synthes Syncage Evolution Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: May 24, 2013 after 268 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: 9 generations back to K841189 (1984). 29 ancestors in all.
143 later devices descend from it; 5 cite it directly.
0 of 173 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.
- K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System, Ldr Spine USA (2009) Summary page 1.
- K081636: Peek-Optima Alif Spacer, Biomet Spine (2008) Summary page 1.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 1.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K111348: RE / Stasis (TM) Gingival Retraction Paste, Centrix, Inc. (2011). Our reading of the summary gave K111348, FDA’s number for RE / Stasis (TM) Gingival Retraction Paste (Centrix, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DePuy Spine Cougar”. Kept off the family tree.

## Most influential descendants
- 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
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own

## Indications for use
The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous 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.

Source page: https://510kreport.com/device/K122639
Methodology: https://510kreport.com/methodology