510(k) · Cleared
ClearedRange, Spinal System, Everest 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 Mar 21, 2014 as substantially equivalent to K032033 (Medtronic Sofamor Danek, 2003) and 12 other predicates after an 88-day review. Its family tree reaches back 16 generations to 1985. 33 later devices descend from it.
- Decided
- Mar 21, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 16 generations to K853033 (1985). 307 ancestors in all, the oldest K781443 (1978). 33 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 2 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 1 generation backK131784 Range Spinal SystemK2m, Inc. · 2013
- This deviceK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · cites it directly · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · 2 generations on · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- Descendant · 3 generations on · 12 of its ownK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · 4 generations on · 11 of its ownK151727 Everest Spinal SystemK2m, Inc. · 2015
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 3 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 2 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 1 generation backK131784 Range Spinal SystemK2m, Inc. · 2013
- This deviceK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · cites it directly30descendants
- K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 2 generations on16descendants
- K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
- K150325Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 3 generations on12descendants
- K151727Everest Spinal SystemK2m, Inc. · 2015 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −3 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −2 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −1 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| 0 (this device) | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +1 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +2 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +2 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
| +3 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +4 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 28 | 0 |
| 2002 | 18 | 0 |
| 2003 | 20 | 0 |
| 2004 | 39 | 0 |
| 2005 | 29 | 0 |
| 2006 | 17 | 0 |
| 2007 | 14 | 0 |
| 2008 | 17 | 0 |
| 2009 | 12 | 0 |
| 2010 | 9 | 0 |
| 2011 | 14 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 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 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? (13)
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 |
|---|---|---|---|
| * | K032033 | CD Horizon Spinal SystemSummary page 1…I, KWP, OSH. NK13 Regulatory Class: Class 1ll 3. Predicate or legally marketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal Sy… | 2003 |
| * | K091445 | CD Horizon Spinal SystemSummary page 1…SH. NK13 Regulatory Class: Class 1ll 3. Predicate or legally marketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103… | 2010 |
| * | K070229 | Range Spinal SystemSummary page 1…Class 1ll 3. Predicate or legally marketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Des… | 2007 |
| * | K121630 | Range Spinal System Our reading of the summary gave K121639, 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”. | 2012 |
| * | K122877 | Range Spinal System, Small StatureSummary page 1…3. Predicate or legally marketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the dev… | 2013 |
| * | K123412 | Range Spinal System, Small Strature ComponentsSummary page 1…cate or legally marketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device:… | 2013 |
| * | K130330 | Range Spinal SystemSummary page 1…egally marketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The R… | 2013 |
| * | K131030 | Range Spinal SystemSummary page 1…rketed devices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The Range and… | 2013 |
| * | K131784 | Range Spinal SystemSummary page 1…vices which are substantially equivalent * Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The Range and Everest S… | 2013 |
| * | K103440 | Everest Spinal SystemSummary page 1…* Medtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The Range and Everest Spinal Systems are top-loading, multiple… | 2011 |
| * | K120656 | Everest Spinal SystemSummary page 1…dtronic CD Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The Range and Everest Spinal Systems are top-loading, multiple component… | 2012 |
| * | K132361 | Everest Spinal SystemSummary page 1…D Horizon K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The Range and Everest Spinal Systems are top-loading, multiple component, posteri… | 2013 |
| * | K132757 | Everest Spinal SystemSummary page 1…K032033. K091445 * K2M Range Spinal System K070229, K121639, KK122877, K123412, K130330. K131030, K131784 * K2M Everest Spinal System K103440, K120656, K132361, K132757 4. Description of the device: The Range and Everest Spinal Systems are top-loading, multiple component, posterior (thora… | 2013 |
What descends from it? (33)
See all 333 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 12 months on median.
- 28 of the 307 ancestors have a recall of any class.
- Of its descendants, K141873 (K2m, Inc., 2014) has gone furthest, with 30 descendants of its own.
- 6 other devices also cite its predicate K032033.
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 AR! 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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor…
Read the full statement (300 words)
RANGE /DENALI/MESA and SMALL STATURE and AR! 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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion. Except for hooks, when used as an anterolatcral thoracic/lumbar system the Range Spinal System may also be used 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 allogiraft Pediatric pedicle screw fixation is limited to a posterior approach.
The EVEREST Spinal System may be used in conjunction with the RANGE's(EA and DENALfl Spinal Systems, all of which 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 stcnosis: curvatures (i.e.. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or railed previous fusion. Except for hooks, when used as an anterolatcral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pcdicle screw fixation in pediatric patients the Everest Spinal System implants arc indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices arc 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/K133944 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133944: Range, Spinal System, Everest Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133944
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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