510(k) · Cleared
ClearedCervical Stand Alone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Apr 14, 2014 as substantially equivalent to K101812 (Orthofix, Inc., 2010) and 3 other predicates after a 202-day review. Its family tree reaches back 11 generations to 1984. 281 later devices descend from it.
- Decided
- Apr 14, 2014
- Review
- 202 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K841189 (1984). 57 ancestors in all. 281 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- This deviceK132999 Cervical Stand Alone SystemOrthofix, Inc. · 2014
- Descendant · cites it directly · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- Descendant · 2 generations on · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- Descendant · 3 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 4 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 2 generations on · 107 of its ownK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- This deviceK132999 Cervical Stand Alone SystemOrthofix, Inc. · 2014
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 281 · See all- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · cites it directly280descendants
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · 2 generations on202descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 3 generations on166descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 4 generations on129descendants
- K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015 · 2 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | 1 |
| 0 (this device) | K132999 | Cervical Stand Alone System | Orthofix, Inc. | 2014 | — |
| +1 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| +3 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +4 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +2 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015 | — |
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 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 15 | 0 |
| 2018 | 11 | 0 |
| 2019 | 21 | 0 |
| 2020 | 23 | 0 |
| 2021 | 24 | 0 |
| 2022 | 23 | 0 |
| 2023 | 32 | 0 |
| 2024 | 39 | 0 |
| 2025 | 47 | 0 |
| 2026 | 36 | 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 |
|---|---|---|---|
| * | K101812 | Construx Mini Peek Spacer SystemSummary page 1…ory Classification: Class 11- 21 CER § 888.3080 - Intervertebral body fusion device Review Panel: Orthopedic Device Panel Predicate Devices: K101812 - CONSTRUX Mini PEEK Spacer System, SE 9/27/10 K091088 - LDR Spine Cervical Interbody Fusion System,… | 2010 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…e Review Panel: Orthopedic Device Panel Predicate Devices: K101812 - CONSTRUX Mini PEEK Spacer System, SE 9/27/10 K091088 - LDR Spine Cervical Interbody Fusion System, SE 07/14/09 K08… | 2009 |
| * | K083389 | Coalition SpacerSummary page 1…/27/10 K091088 - LDR Spine Cervical Interbody Fusion System, SE 07/14/09 K083389 - COALITION Spacer, SE 03/26/09 K102606 - AVS Anchor-C Cervical Cage System, SE 04/22/11 Reason for… | 2009 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 1…rbody Fusion System, SE 07/14/09 K083389 - COALITION Spacer, SE 03/26/09 K102606 - AVS Anchor-C Cervical Cage System, SE 04/22/11 Reason for 510(k) Submission: New product offering Device Description… | 2011 |
What descends from it? (281)
See all 2812 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 30 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 57 ancestors have a recall of any class.
- Of its descendants, K142152 (Orthofix, Inc., 2015) has gone furthest, with 280 descendants of its own.
- 2 other devices also cite its predicate K101812.
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 Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132999: Cervical Stand Alone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132999
Report an extraction error
Are you the manufacturer?
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