510(k) · Cleared
Recalled · Class II · 2017Amendia Stand-Alone Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 14, 2016 as substantially equivalent to K141005 (Zavation, LLC, 2014) after a 98-day review. Its family tree reaches back 15 generations to 1984. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 14, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 15 generations to K841189 (1984). 108 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 2 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 1 generation backK141005 Z-Link CervicalZavation, LLC · 2014
- This deviceK152972 Amendia Stand-Alone Cervical SystemAmendia, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK210044 Crystal Spinal System & Vertu Spinal System, Lucent Spinal System…Spinal Elements, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK230607 SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK210382 Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 3 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 2 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 1 generation backK141005 Z-Link CervicalZavation, LLC · 2014
- This deviceK152972 Amendia Stand-Alone Cervical SystemAmendia, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc. · 2021 · cites it directly1descendant
- K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd. · 2023 · 2 generations on0descendants
- K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| −3 | K112664 | Zavation Ibf Systems | Zavation, LLC | 2011 | — |
| −2 | K120576 | Zavation Ibf System | Zavation, LLC | 2012 | — |
| −1 | K141005 | Z-Link Cervical | Zavation, LLC | 2014 | — |
| 0 (this device) | K152972 | Amendia Stand-Alone Cervical System | Amendia, Inc. | 2016 | — |
| +1 | K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal… | Spinal Elements, Inc. | 2021 | — |
| +2 | K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty), Ltd. | 2023 | — |
| +1 | K210382 | Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 18 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 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 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? (1)
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 |
|---|---|---|---|
| * | K141005 | Z-Link CervicalSummary page 4…Cervical Device Product Code and Classification: OVE, Class II (§888.3080) Primary Predicate: Zavation Z-Link Cervical System (K141005) Device Description: The Amendia Stand-Alone Cervical System includes a PEEK spacer component (medical grade Zeniva ZA-500, ASTM… | 2014 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2017 | Class II | Z-0316-2018 | Mixed-up of materials/components | Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length. |
| Nov 22, 2016 | Class II | Z-0966-2017 | Process control | Absent tantalum market pin. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 108 ancestors have a recall of any class.
- Of its descendants, K210044 (Spinal Elements, Inc., 2021) has gone furthest, with 1 descendant 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. 2016, 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 Amendia Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in
skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from
C2-T1. 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 Amendia Stand-Alone Cervical implant should
be packed with autogenous bone graft and implanted with an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152972 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152972: Amendia Stand-Alone Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152972
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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