510(k) · Cleared
ClearedRange/Mesa/Denali Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 10, 2014 as substantially equivalent to K052398 (K2m, LLC, 2005) and 5 other predicates after a 105-day review. Its family tree reaches back 15 generations to 1985. 15 later devices descend from it.
- Decided
- Jul 10, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K853033 (1985). 257 ancestors in all, the oldest K781443 (1978). 15 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK120656 Everest Spinal SystemK2m, Inc. · 2012
- 2 generations backK132757 Everest Spinal SystemK2m, Inc. · 2013
- 1 generation backK140529 Everest Spinal SystemK2m, LLC · 2014
- This deviceK140765 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
- Descendant · 3 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- 5 generations backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- 4 generations backK113654 CaspianK2m, Inc. · 2012
- 3 generations backK120656 Everest Spinal SystemK2m, Inc. · 2012
- 2 generations backK132757 Everest Spinal SystemK2m, Inc. · 2013
- 1 generation backK140529 Everest Spinal SystemK2m, LLC · 2014
- This deviceK140765 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017 · cites it directly13descendants
- K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · 2 generations on5descendants
- K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018 · 2 generations on5descendants
- K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023 · 3 generations on4descendants
- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K080828 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2008 | — |
| −5 | K110353 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2011 | — |
| −4 | K113654 | Caspian | K2m, Inc. | 2012 | — |
| −3 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| −2 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| −1 | K140529 | Everest Spinal System | K2m, LLC | 2014 | — |
| 0 (this device) | K140765 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +1 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
| +2 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
| +2 | K181119 | Range (Denali and Mesa) Spinal Systems | K2m, Inc. | 2018 | — |
| +3 | K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2023 | — |
| +3 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 10 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 23 | 0 |
| 2002 | 17 | 0 |
| 2003 | 18 | 0 |
| 2004 | 37 | 0 |
| 2005 | 24 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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…rthosis (21 JFR 888.3050) (KWP) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229. K121630, K140529) * Medtronic CD Horizon (K091445) 4. Description of the device: The Range Spinal… | 2005 |
| * | K042635 | Denali Spine SystemSummary page 1…(21 JFR 888.3050) (KWP) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229. K121630, K140529) * Medtronic CD Horizon (K091445) 4. Description of the device: The Range Spinal System i… | 2005 |
| * | K070229 | Range Spinal SystemSummary page 1…(21 JFR 888.3050) (KWP) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229. K121630, K140529) * Medtronic CD Horizon (K091445) 4. Description of the device: The Range Spinal System is a top-… | 2007 |
| * | K121630 | Range Spinal SystemSummary page 1…88.3050) (KWP) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229. K121630, K140529) * Medtronic CD Horizon (K091445) 4. Description of the device: The Range Spinal System is a top-loading,… | 2012 |
| * | K140529 | Everest Spinal System Cleared while this submission was under review Summary page 1…(KWP) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229. K121630, K140529) * Medtronic CD Horizon (K091445) 4. Description of the device: The Range Spinal System is a top-loading, multiple… | 2014 |
| * | K091445 | CD Horizon Spinal SystemSummary page 1…ly marketed devices which are substantially equivalent * K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229. K121630, K140529) * Medtronic CD Horizon (K091445) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar… | 2010 |
What descends from it? (15)
See all 153 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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 26 of the 257 ancestors have a recall of any class.
- Of its descendants, K171832 (K2m, Inc., 2017) has gone furthest, with 13 descendants of its own.
- 16 other devices also cite its predicate K052398.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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); tumnor…
Read the full statement (147 words)
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:
Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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); tumnor pseudarthrosis; and/or failed previous fiusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be wsed for the same indications as an adjunct to fusion.
Except for the AR! staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140765: Range/Mesa/Denali Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140765
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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