510(k) · Cleared
ClearedMesa Spinal System (Keystone Rods)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 2, 2011 after a 116-day review. The FDA summary names its predicate without a number. 55 later devices descend from it.
- Decided
- Aug 2, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
55 later devices descend from it, 2 citing it directly.
- This deviceK110991 Mesa Spinal System (Keystone Rods)K2m, Inc. · 2011
- Descendant · cites it directly · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- Descendant · cites it directly · 38 of its ownK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- Descendant · 2 generations on · 36 of its ownK130330 Range Spinal SystemK2m, Inc. · 2013
- Descendant · 3 generations on · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 34 of its ownK131784 Range Spinal SystemK2m, Inc. · 2013
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly53descendants
- K121016Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly38descendants
- K130330Range Spinal SystemK2m, Inc. · 2013 · 2 generations on36descendants
- K132361Everest Spinal SystemK2m, Inc. · 2013 · 3 generations on34descendants
- K131784Range Spinal SystemK2m, Inc. · 2013 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110991 | Mesa Spinal System (Keystone Rods) | K2m, Inc. | 2011 | — |
| +1 | K120099 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| +1 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| +2 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| +3 | K132361 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2026 | 4 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Mesa Spinal System Named without a submission number | |
| * | — | Range Spinal System Named without a submission number | |
| * | — | Easyspine Named without a submission number |
What descends from it? (55)
See all 552 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?
- Of its descendants, K120099 (K2m, Inc., 2012) has gone furthest, with 53 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ART Anterior Vertebral Body Staples, all of which are cleared for the following indications: Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fuision for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor…
Read the full statement (193 words)
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ART Anterior Vertebral Body Staples, all of which are cleared for the following indications:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fuision for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-SlI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenasis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110991: Mesa Spinal System (Keystone Rods).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110991
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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