510(k) · Cleared
ClearedOria Natura Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 13, 2008 after a 49-day review. The FDA summary names no predicate by number. 508 later devices descend from it.
- Decided
- Feb 13, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
508 later devices descend from it, 5 citing it directly.
- This deviceK073669 Oria Natura SpacerChoicespine, LP · 2008
- Descendant · cites it directly · 470 of its ownK111792 Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model…Signus Medizintechnik GmbH · 2012
- Descendant · 2 generations on · 462 of its ownK131372 Mobis IISignus Medizintechnik GmbH · 2013
- Descendant · 3 generations on · 461 of its ownK141405 Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014
- Descendant · 4 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
Showing 5 of 508 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 508 · See all- K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH · 2012 · cites it directly470descendants
- K131372Mobis IISignus Medizintechnik GmbH · 2013 · 2 generations on462descendants
- K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014 · 3 generations on461descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 4 generations on459descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 5 generations on315descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073669 | Oria Natura Spacer | Choicespine, LP | 2008 | — |
| +1 | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… | Signus Medizintechnik GmbH | 2012 | — |
| +2 | K131372 | Mobis II | Signus Medizintechnik GmbH | 2013 | — |
| +3 | K141405 | Mobis II ST Spinal Implant | Signus Medizintechnik GmbH | 2014 | — |
| +4 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +5 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 27 | 0 |
| 2018 | 28 | 0 |
| 2019 | 34 | 0 |
| 2020 | 50 | 0 |
| 2021 | 45 | 0 |
| 2022 | 56 | 0 |
| 2023 | 67 | 0 |
| 2024 | 76 | 0 |
| 2025 | 57 | 0 |
| 2026 | 48 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (508)
See all 5085 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini | 2012 | 470 |
| K140142 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) | 2014 | 172 |
| K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™… | 2016 | 171 |
| K124012 | Infill Oblique Tlif Device | 2013 | 6 |
| K133126 | K7 Lumbar Spacers | 2013 | 1 |
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?
- Of its descendants, K111792 (Signus Medizintechnik GmbH, 2012) has gone furthest, with 470 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with…
Read the full statement (177 words)
When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from TI to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073669 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073669: Oria Natura Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073669
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