510(k) · Cleared
Recalled · Class II · 2015Exactech Acapella One Cervical Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 12, 2014 as substantially equivalent to K103655 (Exactech, Inc., 2011) and 3 other predicates after a 180-day review. Its family tree reaches back 12 generations to 1984. 47 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 2014
- Review
- 180 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 12 generations to K841189 (1984). 57 ancestors in all. 47 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 2 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 1 generation backK103655 Octane-C Interbody Fusion Device SystemExactech, Inc. · 2011 · Recalled
- This deviceK132582 Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014
- Descendant · cites it directly · 39 of its ownK171489 Acapella Cervical Spacer SystemChoicespine, LP · 2017
- Descendant · 2 generations on · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
- Descendant · cites it directly · 19 of its ownK152099 Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 3 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · cites it directly · 18 of its ownK180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 2 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 1 generation backK103655 Octane-C Interbody Fusion Device SystemExactech, Inc. · 2011 · Recalled
- This deviceK132582 Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K171489Acapella Cervical Spacer SystemChoicespine, LP · 2017 · cites it directly39descendants
- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · 2 generations on25descendants
- K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine · 2016 · cites it directly19descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 3 generations on18descendants
- K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −2 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| −1 | K103655 | Octane-C Interbody Fusion Device System | Exactech, Inc. | 2011 | 1 |
| 0 (this device) | K132582 | Exactech Acapella One Cervical Spacer System | Exactech, Inc. | 2014 | — |
| +1 | K171489 | Acapella Cervical Spacer System | Choicespine, LP | 2017 | — |
| +2 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
| +1 | K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System | Genesys Spine | 2016 | — |
| +3 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +1 | K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Genesys Spine | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103655 | Octane-C Interbody Fusion Device SystemSummary page 1…Cervical Class Il Product Code: OVE Legally Marketed Devices to Which Substantial Equivalence Is Claimed * K103655 - Octane-C Interbody Fusion System * K082801 - US Spine Phantom Plus Cage * KI 13559 - LDR ROI-C Cervical Cage Implant - Lo… | 2011 |
| * | K082801 | Phantom Plus Cage SystemSummary page 1…Class Il Product Code: OVE Legally Marketed Devices to Which Substantial Equivalence Is Claimed * K103655 - Octane-C Interbody Fusion System * K082801 - US Spine Phantom Plus Cage * KI 13559 - LDR ROI-C Cervical Cage Implant - Lordotic * K082270 - Octane-A Interbody Fusion… | 2008 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | 2011 |
| * | K082270 | Octane Vertebral Body Replacement (VBR) SystemSummary page 1…ence Is Claimed * K103655 - Octane-C Interbody Fusion System * K082801 - US Spine Phantom Plus Cage * KI 13559 - LDR ROI-C Cervical Cage Implant - Lordotic * K082270 - Octane-A Interbody Fusion System (material composition only) Device Description The Acapella One Cervical Spacer System is an… | 2008 |
What descends from it? (47)
See all 474 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2015 | Class II | Z-0809-2016 | Process control | 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 Device Parallel (05-090-02-1610) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 57 ancestors have a recall of any class.
- Of its descendants, K171489 (Choicespine, LP, 2017) has gone furthest, with 39 descendants of its own.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132582: Exactech Acapella One Cervical Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132582
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026