510(k) · Cleared
ClearedRange Spinal System, Unit Rod
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 May 25, 2012 as substantially equivalent to K070229 (K2m, Inc., 2007) and 8 other predicates after a 60-day review. Its family tree reaches back 10 generations to 1985. 35 later devices descend from it.
- Decided
- May 25, 2012
- Review
- 60 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 10 generations to K853033 (1985). 55 ancestors in all. 35 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK112920 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
- This deviceK120899 Range Spinal System, Unit RodK2m, Inc. · 2012
- Descendant · cites it directly · 34 of its ownK131030 Range Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · 4 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · 4 generations on · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK112920 Range Spinal System (Mesa and Denali)K2m, Inc. · 2011
- This deviceK120899 Range Spinal System, Unit RodK2m, Inc. · 2012
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K131030Range Spinal SystemK2m, Inc. · 2013 · cites it directly34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 2 generations on33descendants
- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 3 generations on30descendants
- K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 4 generations on16descendants
- K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −1 | K112920 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2011 | — |
| 0 (this device) | K120899 | Range Spinal System, Unit Rod | K2m, Inc. | 2012 | — |
| +1 | K131030 | Range Spinal System | K2m, Inc. | 2013 | — |
| +2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +3 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +4 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +4 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 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? (9)
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 |
|---|---|---|---|
| * | K070229 | Range Spinal SystemSummary page 1…KWP, MNH Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K(070229, K072914,K080792, K08130 1, K10085 1, Kl 12037, KI 12920) * Medtronic TSR{(1(110676) * Synthes USS, Click'X, VAS, Dual… | 2007 |
| * | K072914 | Natural Bridge LP Transverse ConnectorsSummary page 1…H Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K(070229, K072914,K080792, K08130 1, K10085 1, Kl 12037, KI 12920) * Medtronic TSR{(1(110676) * Synthes USS, Click'X, VAS, Dual -Opening,… | 2008 |
| * | K080792 | K2M Cocr RodSummary page 1…latory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K(070229, K072914,K080792, K08130 1, K10085 1, Kl 12037, KI 12920) * Medtronic TSR{(1(110676) * Synthes USS, Click'X, VAS, Dual -Opening, Small S… | 2008 |
| * | K081381 | Range Spinal System, Large Denali Screws Our reading of the summary gave K081301, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “K2M Range Spinal System”. | 2008 |
| * | K100851 | Range Spinal SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K(070229, K072914,K080792, K08130 1, K10085 1, Kl 12037, KI 12920) * Medtronic TSR{(1(110676) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K022949) 4… | 2010 |
| * | K112037 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K112920 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K110676 | TSRH Spinal SystemSummary page 1…ed devices which are substantially equivalent: * K2M Range Spinal System (K(070229, K072914,K080792, K08130 1, K10085 1, Kl 12037, KI 12920) * Medtronic TSR{(1(110676) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K022949) 4. Description of the device: The Range Spin… | 2011 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…ystem (K(070229, K072914,K080792, K08130 1, K10085 1, Kl 12037, KI 12920) * Medtronic TSR{(1(110676) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K022949) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, postenior (thoracic-lumba… | 2003 |
What descends from it? (35)
See all 352 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?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 55 ancestors has a recall.
- Of its descendants, K131030 (K2m, Inc., 2013) has gone furthest, with 34 descendants of its own.
- 23 other devices also cite its predicate K070229.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 (193 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 -S I vertebra in skeletally matue 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; traumna ( 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/K120899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120899: Range Spinal System, Unit Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120899
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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