# K120275: Synthes Acis/Vertebral Spacer CR

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa), LLC
- Decided: May 25, 2012 after 116 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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 K003155 (2001). 68 ancestors in all.
173 later devices descend from it; 12 cite it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 1.
- K073285: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS 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, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 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
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own

## Indications for use
The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation. The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K120275
Methodology: https://510kreport.com/methodology