510(k) Report

510(k) · Cleared

Cleared

Range/Denali/Mesa Spinal System

K171832510(k) TraditionalCleared Sep 14, 201786-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 14, 2017 as substantially equivalent to K141873 (K2m, Inc., 2014) and 5 other predicates after an 86-day review. Its family tree reaches back 18 generations to 1985. 13 later devices descend from it.

Decided
Sep 14, 2017
Review
86 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 18 generations to K853033 (1985). 318 ancestors in all, the oldest K781443 (1978). 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2012: 8 other ancestors2009: 13 other ancestors2007: 14 other ancestors2011: 14 other ancestors2010: 10 other ancestors2008: 17 other ancestors2006: 18 other ancestors2005: 30 other ancestors2002: 18 other ancestors2000: 18 other ancestors2013: 6 other ancestors2004: 40 other ancestors2003: 20 other ancestors2001: 28 other ancestors1999: 12 other ancestors1998: 11 other ancestors1997: 3 other ancestors1996: 8 other ancestors1994: 1 other ancestor1978: 1 other ancestor1995: 5 other ancestors1990: 1 other ancestor1984: 1 other ancestor1993: 1 other ancestor2018: 3 descendants cleared2024: 7 descendants cleared2023: 2 descendants cleared2026: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001×2: 2 generations cleared close together, K022190 (2002), K030103 (2003) K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K111571 · Viper Systems · Johnson & Johnson · 2011K121016 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012×2: 2 generations cleared close together, K130330 (2013), K131784 (2013) ×2: 2 generations cleared close together, K133944 (2014), K141873 (2014) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 24 other ancestors3 generations back: 71 other ancestors4 generations back: 70 other ancestors5 generations back: 39 other ancestors6 generations back: 37 other ancestors7 generations back: 32 other ancestors8 generations back: 13 other ancestors9 generations back: 8 other ancestors10 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants K141873 · Range/Mesa/Denali Spinal System · K2m, Inc. · 2014K133944 · Range, Spinal System, Everest Spinal System · K2m, Inc. · 2014K131784 · Range Spinal System · K2m, Inc. · 2013K130330 · Range Spinal System · K2m, Inc. · 2013K121016 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012K111571 · Viper Systems · Johnson & Johnson · 2011K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−15−10−50
  1. Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 14 generations between
  3. 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
  4. 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  5. 1 generation backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  6. This deviceK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
  7. Descendant · cites it directly · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
  8. Descendant · cites it directly · 5 of its ownK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
  9. Descendant · 2 generations on · 4 of its ownK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
  10. Descendant · 2 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
  11. Descendant · 3 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
Show all 18 generations
  1. Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 17 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 16 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 15 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 14 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 13 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 12 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 11 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 10 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 9 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 8 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 7 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 6 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  14. 5 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  15. 4 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
  16. 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
  17. 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  18. 1 generation backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  19. This deviceK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2018: 32023: 22024: 72026: 1
2018high 7 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 13 · See all
  • K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · cites it directly5descendants
  • K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018 · cites it directly5descendants
  • K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023 · 2 generations on4descendants
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 2 generations on4descendants
  • K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−17K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−16K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−15K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−14K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−13K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−12K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−11K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−10K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−9K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−8K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−7K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−6K111571Viper SystemsJohnson & Johnson2011—
−5K121016Range Spinal System (Mesa and Denali)K2m, Inc.2012—
−4K130330Range Spinal SystemK2m, Inc.2013—
−3K131784Range Spinal SystemK2m, Inc.2013—
−2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—
−1K141873Range/Mesa/Denali Spinal SystemK2m, Inc.2014—
0 (this device)K171832Range/Denali/Mesa Spinal SystemK2m, Inc.2017—
+1K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT…K2m, Inc.2018—
+1K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.2018—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.2023—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System…Stryker Spine2023—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199010
199310
199410
199550
199680
199730
1998110
1999120
2000180
2001280
2002180
2003200
2004400
2005300
2006180
2007140
2008170
2009130
2010100
2011140
201280
201360
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201830
202320
202470
202610
FIG. 1 — Lineage of K171832, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K141873Range/Mesa/Denali Spinal System
Summary page 4
…duct Code: KWQ) Spinal Interlaminal fixation Orthosis (21 CFR 888.3050, Product Code: KWP) Predicate Device(s) Primary Predicates: K2M Range/Denali/Mesa Spinal System (K141873) Additional Predicates: K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K140765) Medicrea PASS LP (K083810) De…
K2m, Inc.2014—
*K070229Range Spinal System
Summary page 4
…, Product Code: KWP) Predicate Device(s) Primary Predicates: K2M Range/Denali/Mesa Spinal System (K141873) Additional Predicates: K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K140765) Medicrea PASS LP (K083810) Device Description The Range/Denali/Mesa Spinal System is a top-loading,…
K2m, Inc.2007—
*K120099Range Spinal System (Mesa and Denali)
Summary page 4
…Code: KWP) Predicate Device(s) Primary Predicates: K2M Range/Denali/Mesa Spinal System (K141873) Additional Predicates: K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K140765) Medicrea PASS LP (K083810) Device Description The Range/Denali/Mesa Spinal System is a top-loading, multiple…
K2m, Inc.2012—
*K121630Range Spinal System
Summary page 4
…P) Predicate Device(s) Primary Predicates: K2M Range/Denali/Mesa Spinal System (K141873) Additional Predicates: K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K140765) Medicrea PASS LP (K083810) Device Description The Range/Denali/Mesa Spinal System is a top-loading, multiple componen…
K2m, Inc.2012—
*K140765Range/Mesa/Denali Spinal System
Summary page 4
…icate Device(s) Primary Predicates: K2M Range/Denali/Mesa Spinal System (K141873) Additional Predicates: K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K140765) Medicrea PASS LP (K083810) Device Description The Range/Denali/Mesa Spinal System is a top-loading, multiple component, poster…
K2m, Inc.2014—
*K083810Pass LP Spinal System
Summary page 4
…dicates: K2M Range/Denali/Mesa Spinal System (K141873) Additional Predicates: K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K140765) Medicrea PASS LP (K083810) Device Description The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoracic- lumbar) spin…
Medicrea Technologies2009—

Also cleared against K141873: 6 other devices →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185
K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185
K180376K2M Patient Specific RodsK2m, Inc.20182

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 32 years and passes through 7 companies; a new generation was cleared every 12 months on median.
  • 29 of the 318 ancestors have a recall of any class.
  • Of its descendants, K181603 (K2m, Inc., 2018) has gone furthest, with 5 descendants of its own.
  • 6 other devices also cite its predicate K141873.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

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); tumor…

Read the full statement (148 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); tumor: pseudarthrosis: 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 RANGE Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical 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.

Also cleared against K141873

6 other devices cite the same predicate.

  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016
  • K161369EVEREST Spinal SystemK2m, Incorporated · 2016
  • K160208NILE Alternative Fixation Spinal SystemK2m, Inc. · 2016
  • K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated · 2015
  • K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K171832 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171832: Range/Denali/Mesa Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171832

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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