510(k) · Cleared
ClearedRange (Denali and Mesa) Spinal Systems
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 Jun 26, 2018 as substantially equivalent to K171832 (K2m, Inc., 2017) and 1 other predicate after a 60-day review. Its family tree reaches back 19 generations to 1985. 5 later devices descend from it.
- Decided
- Jun 26, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K853033 (1985). 398 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations between
- 3 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 2 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 1 generation backK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- This deviceK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 19 generations
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 17 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 16 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 15 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 14 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 13 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 12 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 11 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 10 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 8 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 7 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 6 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 5 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 4 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 3 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 2 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 1 generation backK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- This deviceK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023 · cites it directly4descendants
- K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 2 generations on3descendants
- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · 3 generations on2descendants
- K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on1descendant
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −18 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −17 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −16 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −15 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −14 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −13 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −12 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −11 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −10 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −8 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −7 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −6 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −5 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −4 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −3 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −2 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −1 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
| 0 (this device) | K181119 | Range (Denali and Mesa) Spinal Systems | K2m, Inc. | 2018 | — |
| +1 | K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2023 | — |
| +2 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
| +3 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated… | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +3 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 12 | 0 |
| 1999 | 15 | 0 |
| 2000 | 19 | 0 |
| 2001 | 33 | 0 |
| 2002 | 20 | 0 |
| 2003 | 23 | 0 |
| 2004 | 40 | 0 |
| 2005 | 35 | 0 |
| 2006 | 24 | 0 |
| 2007 | 21 | 0 |
| 2008 | 23 | 0 |
| 2009 | 22 | 0 |
| 2010 | 17 | 0 |
| 2011 | 20 | 0 |
| 2012 | 13 | 0 |
| 2013 | 9 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 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? (2)
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 |
|---|---|---|---|
| * | K171832 | Range/Denali/Mesa Spinal SystemSummary page 4…de: KWQ) Spinal Interlaminal fixation Orthosis (21 CFR 888.3050, Product Code: KWP) Predicate Device(s) Primary Predicates: K2M Range (Denali and Mesa) Spinal Systems (K171832) Additional Predicates: K2M EVEREST Spinal System (K173508) Device Description The Range (Denali and Mesa) Spinal Systems are… | 2017 |
| * | K173508 | Everest Spinal SystemSummary page 4…050, Product Code: KWP) Predicate Device(s) Primary Predicates: K2M Range (Denali and Mesa) Spinal Systems (K171832) Additional Predicates: K2M EVEREST Spinal System (K173508) Device Description The Range (Denali and Mesa) Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar)… | 2018 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232341 | CarboClear® Pedicle Screw System | 2023 | 4 |
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 33 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 40 of the 398 ancestors have a recall of any class.
- Of its descendants, K232341 (CarboFix Orthopedics, Ltd., 2023) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K171832.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The MESA and DENALL Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications: Posterior 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.…
Read the full statement (162 words)
The MESA and DENALL Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior 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); tumor; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181119: Range (Denali and Mesa) Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181119
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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