# K141798: Sypher Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Biogennix, LLC
- Decided: Feb 19, 2015 after 231 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 13 generations back to K841189 (1984). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120031: Chesapeake Spinal System, K2m, Inc. (2012) Summary page 5.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 5.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 5.
- K130913: Genesys Spine Apache Lateral Lumbar Interbody Fusion System, Genesys Spine (2013) Summary page 5.

## Most influential descendants
- K181337: Sypher Spacer System (2018), 0 descendants of its own

## Indications for use
The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation to facilitate fusion.

Source page: https://510kreport.com/device/K141798
Methodology: https://510kreport.com/methodology