# K102957: Cutting Edge Spine Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Cutting Edge Spine, LLC
- Decided: Apr 28, 2011 after 205 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: 1 generation back to P950002 (1996). 4 ancestors in all.
93 later devices descend from it; 5 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090707: Talos Intervertebral Body Fusion Device, Meditech Advisors, LLC (2009) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 2.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 2.

## Most influential descendants
- K150321: EVOS Lumbar Interbody System (2015), 92 descendants of its own
- K153615: NeoFuse HA Enhanced PLIF/TLIF (2016), 50 descendants of its own
- K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody (2017), 49 descendants of its own
- K192115: SABLE Expandable Spacer (2020), 37 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own

## Indications for use
The Cutting Edge Spine Interbody Fusion Device (CES) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L-2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The CES device is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The CES device is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K102957
Methodology: https://510kreport.com/methodology