# K141129: Exactech Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Aug 15, 2014 after 106 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: 14 generations back to K003155 (2001). 107 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121649: Construx Mini Peek TI Spacer System, Orthofix (2012) Summary page 6.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 6.
- K120486: Avs as Peek Spacer, Stryker Spine (2012) Summary page 6.
- K130317: Genesys Spine Apache Ibfd Star Cervical System, Genesys Spine (2013) Summary page 6.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 6.
- K121103: LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa MC Implant S, Ldr Spine USA, Inc. (2012) Summary page 6.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 6.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 6.
- K130948: C-Fuse Cervical Intervertebral Body Fusion System, Southern Spine, LLC (2013) Summary page 6.

## Most influential descendants
- K150130: Ascendant TM Cervical Spacer System (2015), 7 descendants of its own
- K191621: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (2019), 4 descendants of its own
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System (2023), 2 descendants of its own
- K203444: BEE HA Cage (2021), 1 descendant of its own

## Indications for use
The Exactech Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (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 Exactech Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K141129
Methodology: https://510kreport.com/methodology