510(k) · Cleared
ClearedAyers Rock Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualgenix · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 1, 2012 as substantially equivalent to K080588 (Scient'X USA, Inc., 2008) and 1 other predicate after a 217-day review. Its family tree reaches back 3 generations to 1996. 1 of the 10 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 1, 2012
- Review
- 217 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P950002 (1996). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK073202 Ardis SpacerAbbott Spine, Inc. · 2008 · Recalled (Class I)
- 1 generation backK080588 Scient'x Tribeca VBRScient'X USA, Inc. · 2008
- This deviceK112801 Ayers Rock Cervical CageQualgenix · 2012
- Descendant · cites it directly · 0 of its ownK163265 Kepler IIOrbbo Surgical, LLC · 2017
- Descendant · cites it directly · 0 of its ownK162694 Ayers Rock Cervical interbody fusion systemSpineway · 2017
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K073202 | Ardis Spacer | Abbott Spine, Inc. | 2008 | Class I |
| −1 | K080588 | Scient'x Tribeca VBR | Scient'X USA, Inc. | 2008 | — |
| 0 (this device) | K112801 | Ayers Rock Cervical Cage | Qualgenix | 2012 | — |
| +1 | K163265 | Kepler II | Orbbo Surgical, LLC | 2017 | — |
| +1 | K162694 | Ayers Rock Cervical interbody fusion system | Spineway | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K080588 | Scient'x Tribeca VBRSummary page 1…ly cleared devices and has the same indications for use, design, and function. Predicate devices include the LOR Spine MC+ (K080588) and SpineArt Tryptik (K091873).… | 2008 |
| * | K091873 | Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSummary page 1…same indications for use, design, and function. Predicate devices include the LOR Spine MC+ (K080588) and SpineArt Tryptik (K091873). fa~e(of… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 7 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K163265 (Orbbo Surgical, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K080588.
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. 2012, 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 Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-Ti. DDID is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112801: Ayers Rock Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112801
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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