510(k) · Cleared
ClearedRange Spinal System (Mesa and Denali)
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 Dec 21, 2011 as substantially equivalent to K052398 (K2m, LLC, 2005) and 4 other predicates after a 79-day review. Its family tree reaches back 9 generations to 1985. 49 later devices descend from it.
- Decided
- Dec 21, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K853033 (1985). 37 ancestors in all. 49 later devices descend from it, 7 citing it directly.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK112920 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
- Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 38 of its ownK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- Descendant · cites it directly · 36 of its ownK130330 Range Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 35 of its ownK120899 Range Spinal System, Unit RodK2m, Inc. · 2012
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK112920 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
- K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
- K121016Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly38descendants
- K130330Range Spinal SystemK2m, Inc. · 2013 · cites it directly36descendants
- K120899Range Spinal System, Unit RodK2m, Inc. · 2012 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K112920 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2011 | — |
| +1 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| +2 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +1 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| +1 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| +1 | K120899 | Range Spinal System, Unit Rod | K2m, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K052398 | Mesa Spinal SystemSummary page 1…N!, KWP, MNH- Regulatory Class: Class II 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K052398, K08061 1, K081381, K(070229) * DePuy Expedium (K(062 174) 4. Description of the device: The Range Spinal System is… | 2005 |
| * | K080611 | Mesa Spinal SystemSummary page 1…MNH- Regulatory Class: Class II 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K052398, K08061 1, K081381, K(070229) * DePuy Expedium (K(062 174) 4. Description of the device: The Range Spinal System is a top-loa… | 2009 |
| * | K081381 | Range Spinal System, Large Denali ScrewsSummary page 1…ulatory Class: Class II 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K052398, K08061 1, K081381, K(070229) * DePuy Expedium (K(062 174) 4. Description of the device: The Range Spinal System is a top-loading, mul… | 2008 |
| * | K070229 | Range Spinal SystemSummary page 1…ss: Class II 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K052398, K08061 1, K081381, K(070229) * DePuy Expedium (K(062 174) 4. Description of the device: The Range Spinal System is a top-loading, multiple comp… | 2007 |
| * | K062174 | Modification to Expedium Spine System | 2006 |
What descends from it? (49)
See all 497 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120656 | Everest Spinal System | 2012 | 43 |
| K121016 | Range Spinal System (Mesa and Denali) | 2012 | 38 |
| K130330 | Range Spinal System | 2013 | 36 |
| K120899 | Range Spinal System, Unit Rod | 2012 | 35 |
| K131030 | Range Spinal System | 2013 | 34 |
| K140529 | Everest Spinal System | 2014 | 31 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System… | 2024 | 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 37 ancestors has a recall.
- Of its descendants, K120656 (K2m, Inc., 2012) has gone furthest, with 43 descendants of its own.
- 16 other devices also cite its predicate K052398.
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 ARI 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 fusion 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 (191 words)
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI 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 fusion 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-S1 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 stenosis; 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/K112920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112920: Range Spinal System (Mesa and Denali).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112920
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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