510(k) · Cleared
Recalled · Class II · 2024Avs Anchor-C Cervical Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Apr 22, 2011 as substantially equivalent to K091088 (Ldr Spine USA, 2009) and 5 other predicates after a 224-day review. Its family tree reaches back 10 generations to 1984. 384 later devices descend from it. It has been recalled once.
- Decided
- Apr 22, 2011
- Review
- 224 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 10 generations to K841189 (1984). 42 ancestors in all. 384 later devices descend from it, 17 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011
- Descendant · cites it directly · 281 of its ownK132999 Cervical Stand Alone SystemOrthofix, Inc. · 2014
- Descendant · 2 generations on · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- Descendant · cites it directly · 206 of its ownK120819 Stalif CCentinel Spine, Inc. · 2012
- Descendant · 3 generations on · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- Descendant · 4 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011
Showing 5 of 384 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 384 · See all- K132999Cervical Stand Alone SystemOrthofix, Inc. · 2014 · cites it directly281descendants
- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · 2 generations on280descendants
- K120819Stalif CCentinel Spine, Inc. · 2012 · cites it directly206descendants
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · 3 generations on202descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 4 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | — |
| +1 | K132999 | Cervical Stand Alone System | Orthofix, Inc. | 2014 | — |
| +2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +1 | K120819 | Stalif C | Centinel Spine, Inc. | 2012 | — |
| +3 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| +4 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
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 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 13 | 0 |
| 2016 | 9 | 0 |
| 2017 | 23 | 0 |
| 2018 | 18 | 0 |
| 2019 | 25 | 0 |
| 2020 | 31 | 0 |
| 2021 | 32 | 0 |
| 2022 | 35 | 0 |
| 2023 | 48 | 0 |
| 2024 | 47 | 0 |
| 2025 | 52 | 0 |
| 2026 | 43 | 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? (6)
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 |
|---|---|---|---|
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…Product Code ODP Predicate Devices The AVS® Anchor-C Cervical Cage System was shown to be substantially equivalent to the devices listed below: o LDR MC+, 510(k) # K091088 Surgicraft STALIF C, 510(k) #K072415 Depuy Bengal #K081917 o Spinal Elements Crystal #K073351 e Zimmer BAK/C # P980048 Medtr… | 2009 |
| * | K072415 | Stalif (TM) CSummary page 1…The AVS® Anchor-C Cervical Cage System was shown to be substantially equivalent to the devices listed below: o LDR MC+, 510(k) # K091088 Surgicraft STALIF C, 510(k) #K072415 Depuy Bengal #K081917 o Spinal Elements Crystal #K073351 e Zimmer BAK/C # P980048 Medtronic AFFINITY #P000028 Device Descrip… | 2008 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…vical Cage System was shown to be substantially equivalent to the devices listed below: o LDR MC+, 510(k) # K091088 Surgicraft STALIF C, 510(k) #K072415 Depuy Bengal #K081917 o Spinal Elements Crystal #K073351 e Zimmer BAK/C # P980048 Medtronic AFFINITY #P000028 Device Description The AVS® Anchor-C… | 2009 |
| * | K073351 | CrystalSummary page 1…bstantially equivalent to the devices listed below: o LDR MC+, 510(k) # K091088 Surgicraft STALIF C, 510(k) #K072415 Depuy Bengal #K081917 o Spinal Elements Crystal #K073351 e Zimmer BAK/C # P980048 Medtronic AFFINITY #P000028 Device Description The AVS® Anchor-C Cervical Cage is a hollow, rectangu… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…the devices listed below: o LDR MC+, 510(k) # K091088 Surgicraft STALIF C, 510(k) #K072415 Depuy Bengal #K081917 o Spinal Elements Crystal #K073351 e Zimmer BAK/C # P980048 Medtronic AFFINITY #P000028 Device Description The AVS® Anchor-C Cervical Cage is a hollow, rectangular- shaped PEEK Optima® L… | 2001 |
| * | P000028 | Affinity (TM) Cage SystemSummary page 1…LDR MC+, 510(k) # K091088 Surgicraft STALIF C, 510(k) #K072415 Depuy Bengal #K081917 o Spinal Elements Crystal #K073351 e Zimmer BAK/C # P980048 Medtronic AFFINITY #P000028 Device Description The AVS® Anchor-C Cervical Cage is a hollow, rectangular- shaped PEEK Optima® LTI (per ASTM F2026) cage asse… | 2002 |
What descends from it? (384)
See all 38417 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132999 | Cervical Stand Alone System | 2014 | 281 |
| K120819 | Stalif C | 2012 | 206 |
| K152532 | AERO -C Cervical Cage System | 2015 | 145 |
| K113796 | Solitaire-C Cervical Spacer System | 2012 | 142 |
| K152515 | TOMCAT Cervical Spinal System | 2015 | 108 |
| K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation | 2014 | 38 |
| K152793 | Unison-C Anterior Cervical Fixation System | 2016 | 29 |
| K173077 | Cavetto-SA Cervical Cage System | 2018 | 21 |
| K181621 | Stable-C Interbody System | 2018 | 7 |
| K172424 | Velofix™ SA Cervical Cage | 2017 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2024 | Class II | Z-3210-2024 | Labeling Change Control | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K132999 (Orthofix, Inc., 2014) has gone furthest, with 281 descendants of its own.
- 50 other devices also cite its predicate K091088.
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. 2011, 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 Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression…
Read the full statement (123 words)
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102606: Avs Anchor-C Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102606
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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