510(k) · Cleared
ClearedExactech Cervical Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 15, 2014 as substantially equivalent to K121649 (Orthofix, 2012) and 8 other predicates after a 106-day review. Its family tree reaches back 14 generations to 2001. 8 later devices descend from it.
- Decided
- Aug 15, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 14 generations to K003155 (2001). 107 ancestors in all, the oldest K841189 (1984). 8 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- This deviceK141129 Exactech Cervical Spacer SystemExactech, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK150130 Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical…Choice Spine, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK203311 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021
- Descendant · 3 generations on · 2 of its ownK223869 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK203444 BEE HA CageNGMedical GmbH · 2021
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- This deviceK141129 Exactech Cervical Spacer SystemExactech, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150130Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015 · cites it directly7descendants
- K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC · 2019 · cites it directly4descendants
- K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021 · 2 generations on3descendants
- K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2023 · 3 generations on2descendants
- K203444BEE HA CageNGMedical GmbH · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −8 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −3 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −1 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| 0 (this device) | K141129 | Exactech Cervical Spacer System | Exactech, Inc. | 2014 | — |
| +1 | K150130 | Ascendant TM Cervical Spacer System | Exactech, Inc. | 2015 | — |
| +1 | K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody… | Choice Spine, LLC | 2019 | — |
| +2 | K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2021 | — |
| +3 | K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2023 | — |
| +2 | K203444 | BEE HA Cage | NGMedical GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 11 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K121649 | Construx Mini Peek TI Spacer SystemSummary page 6…Trade or Proprietary or Model Name Manufacturer Orthofix K121649 CONSTRUX™ MINI Spacer System S… | 2012 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 6…Orthofix K121649 CONSTRUX™ MINI Spacer System Spinal K090064 Copperhead System Eminent Spine K120486 AVS AS System… | 2009 |
| * | K120486 | Avs as Peek SpacerSummary page 6…Spinal K090064 Copperhead System Eminent Spine K120486 AVS AS System Stryker Spine K130317, Apache™ Interbod… | 2012 |
| * | K130317 | Genesys Spine Apache Ibfd Star Cervical SystemSummary page 6…Copperhead System Eminent Spine K120486 AVS AS System Stryker Spine K130317, Apache™ Interbody Fusion System Star Cervical… | 2013 |
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 6…K130317, Apache™ Interbody Fusion System Star Cervical Genesys Spine K103034 PEEK K121103, K113559, Spine MC+ Cervical Cage LDR K091088 K… | 2010 |
| * | K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Summary page 6…he™ Interbody Fusion System Star Cervical Genesys Spine K103034 PEEK K121103, K113559, Spine MC+ Cervical Cage LDR K091088 K130948 Cervica… | 2012 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 6…ody Fusion System Star Cervical Genesys Spine K103034 PEEK K121103, K113559, Spine MC+ Cervical Cage LDR K091088 K130948 Cervical IBFD… | 2011 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 6…Genesys Spine K103034 PEEK K121103, K113559, Spine MC+ Cervical Cage LDR K091088 K130948 Cervical IBFD Southern Spine PERFORMANCE DATA The Cervical S… | 2009 |
| * | K130948 | C-Fuse Cervical Intervertebral Body Fusion SystemSummary page 6…Genesys Spine K103034 PEEK K121103, K113559, Spine MC+ Cervical Cage LDR K091088 K130948 Cervical IBFD Southern Spine PERFORMANCE DATA The Cervical Spacer Sys… | 2013 |
What descends from it? (8)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 12 of the 107 ancestors have a recall of any class.
- Of its descendants, K150130 (Exactech, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K121649.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141129: Exactech 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/K141129
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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