# K132582: Exactech Acapella One Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 12, 2014 after 180 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K841189 (1984). 57 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103655: Octane-C Interbody Fusion Device System, Exactech, Inc. (2011) Summary page 1.
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 1.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011)
- K082270: Octane Vertebral Body Replacement (VBR) System, Vertiflex, Inc. (2008) Summary page 1.

## Most influential descendants
- K171489: Acapella Cervical Spacer System (2017), 39 descendants of its own
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own
- K152099: Genesys Spine Apache® Anchored Cervical Interbody Fusion System (2016), 19 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K180056: Genesys Spine AIS-C Cervical Anchored Interbody System (2018), 18 descendants of its own

## Recalls of this device
- Sep 28, 2015 · Class II · Z-0809-2016: Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion De

## Indications for use
The Exactech Acapella One 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 Acapella One 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.

Source page: https://510kreport.com/device/K132582
Methodology: https://510kreport.com/methodology