510(k) Report

510(k) · Cleared

Cleared

Range Spinal System, Small Stature

K122877510(k) SpecialCleared May 8, 2013231-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. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Cleared on May 8, 2013 as substantially equivalent to K120099 (K2m, Inc., 2012) and 14 other predicates after a 231-day review. Its family tree reaches back 13 generations to 2004. 34 later devices descend from it.

Decided
May 8, 2013
Review
231 days
Class
Class II
Product code
OSH
Recalls
None
Predicates
15

Its longest line of descent runs back 13 generations to K040583 (2004). 185 ancestors in all, the oldest K781443 (1978). 34 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 4 other ancestors2011: 7 other ancestors2010: 4 other ancestors2009: 5 other ancestors2002: 10 other ancestors2008: 12 other ancestors2007: 5 other ancestors2006: 13 other ancestors2005: 19 other ancestors2004: 24 other ancestors2003: 12 other ancestors2000: 15 other ancestors1999: 3 other ancestors1998: 8 other ancestors1997: 3 other ancestors1996: 6 other ancestors1994: 1 other ancestor2001: 16 other ancestors1978: 1 other ancestor1995: 3 other ancestors1984: 1 other ancestor2015: 4 descendants cleared2014: 4 descendants cleared2024: 7 descendants cleared2016: 3 descendants cleared2017: 2 descendants cleared2021: 1 descendant cleared2026: 2 descendants cleared2022: 2 descendants cleared2023: 3 descendants cleared2018: 5 descendants cleared2020: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121630 · Range Spinal System · K2m, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 38 other ancestors3 generations back: 59 other ancestors4 generations back: 40 other ancestors5 generations back: 21 other ancestors6 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 3 descendants7 generations forward: 2 descendants K121630 · Range Spinal System · K2m, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50+5
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations between
  3. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  4. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  5. 1 generation backK121630 Range Spinal SystemK2m, Inc. · 2012
  6. This deviceK122877 Range Spinal System, Small StatureK2m, Inc. · 2013
  7. Descendant · cites it directly · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  8. Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  9. Descendant · 3 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  10. Descendant · 3 generations on · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
  11. Descendant · cites it directly · 12 of its ownK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
Show all 13 generations
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 1 generation backK121630 Range Spinal SystemK2m, Inc. · 2012
  14. This deviceK122877 Range Spinal System, Small StatureK2m, Inc. · 2013

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2014: 42015: 42016: 32017: 22018: 52020: 12021: 12022: 22023: 32024: 72026: 2
2014high 7 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 34 · See all
  • K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · cites it directly33descendants
  • K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 2 generations on30descendants
  • K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 3 generations on16descendants
  • K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017 · 3 generations on13descendants
  • K150325Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · cites it directly12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−10K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−8K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−7K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−6K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−5K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−1K121630Range Spinal SystemK2m, Inc.2012—
0 (this device)K122877Range Spinal System, Small StatureK2m, Inc.2013—
+1K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.2014—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.2015—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.2017—
+1K150325Range/Denali/Mesa Spinal SystemK2m, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199410
199530
199660
199730
199880
199930
2000150
2001160
2002100
2003120
2004240
2005190
2006130
200750
2008120
200950
201040
201170
201240

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201440
201540
201630
201720
201850
202010
202110
202220
202330
202470
202620
FIG. 1 — Lineage of K122877, 2004–2026Source: 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 OSH? 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
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What was it cleared against? (15)

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
*K120099Range Spinal System (Mesa and Denali)
Summary page 1
…KWP, MNH, OSH Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 11007…
K2m, Inc.2012—
*K121630Range Spinal System
Summary page 1
…OSH Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 119…
K2m, Inc.2012—
*K090230Expedium Spine System
Summary page 1
…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457,…
Depuy Spine, Inc.2009—
*K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc.20121
*K020709Modification to CD Horizon Spinal System
Summary page 1
…d devices which are substantially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of…
Medtronic Sofamor Danek2002—
*K091445CD Horizon Spinal System
Summary page 1
…which are substantially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the devi…
Medtronic Sofamor Danek2010—
*K102555CD Horizon Spinal System
Summary page 1
…e substantially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the device:…
Medtronic Sofamor Danek USA, Inc.2010—
*K102807CD Horizon Spinal System
Summary page 1
…ially equivalent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the device: The Ran…
Medtronic Sofamor Danek, Inc.2010—
*K110070TSRH Spinal System
Summary page 1
…valent: * K2M Range Spinal System (K 120099, K 121630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the device: The Range Spinal…
Medtronic Sofamor Danck USA, Inc.2011—
*K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011—
*K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
*K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011—
*K112555CD Horizon (R) Spinal System
Summary page 1
…21630) . DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the device: The Range Spinal System is atop-loading, multiple component, posterio…
Medtronic Sofamor Danek USA, Inc.2011—
*K112473CD Horizon Spinal System
Summary page 1
…. DePuy Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the device: The Range Spinal System is atop-loading, multiple component, posterior (thoraci…
Medtronic Sofamor Danek, Inc.2011—
*K113174CD Horizon Spinal System
Summary page 1
…y Expediumo (K090230, K 11I1136) * Medtronic CD Legacy (K020709, K091445, K 102555, K 102807. K 110070, K I 11942, K I 115 10, K I11457, K 112555, K 112473, 113174) 4. Description of the device: The Range Spinal System is atop-loading, multiple component, posterior (thoracic-lumbar…
Medtronic Sofamor Danek USA, Inc.20111

Also cleared against K120099: 9 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433
K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512

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 9 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 20 of the 185 ancestors have a recall of any class.
  • Of its descendants, K133944 (K2m, Inc., 2014) has gone furthest, with 33 descendants of its own.
  • 9 other devices also cite its predicate K120099.

How does its category compare?

All OSH devices

OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OSH

1in 2016

2012: 32013: 142014: 12016: 1
2007high 14 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OSH

82in 2013

2012: 76 days median2013: 82 days median
2007high 82 (2013) · low 76 (2012)2026

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

Recalls per year · OSH

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OSH

3in 2025

2009: 12011: 12012: 12013: 22014: 12015: 32016: 92017: 42018: 142019: 122020: 122021: 22022: 82023: 182024: 122025: 3
2007high 18 (2023) · low 0 (2007)2025

MAUDE reports naming product code OSH, 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
20070—00
20080—00
20090—01
20100—00
20110—01
201237601
2013148202
20141—01
20150—03
20161—09
20170—14
20180—014
20190—012
20200—012
20210—02
20220—08
20230—018
20240—012
20250—03
20260—0—

What is it indicated for?

RANGE /DENALI, MESA and SMALL STATURE and AR] 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…

Read the full statement (234 words)

RANGE /DENALI, MESA and SMALL STATURE and AR] 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 LS-SlI vertebra in skeletally mature 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, in skeletally mature patients, 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; trauma ( i.e. fracture or dislocation); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous 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.

Also cleared against K120099

9 other devices cite the same predicate.

  • K171832Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016
  • K150325Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
  • K143350Nile Alternative FixationK2m, Inc. · 2015
  • K131784Range Spinal SystemK2m, Inc. · 2013
  • K131030Range Spinal SystemK2m, Inc. · 2013

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 OSH

The OSH category page

  • K153446OLYMPIC Posterior Spinal Fixation SystemAstura Medical · 2016
  • K140276CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  • K132574Pass LP Spinal SystemMedicrea International · 2013
  • K132303Implanet Spine SystemImplanet, S.A. · 2013
  • K132575Pass LP Spinal SystemMedicrea International · 2013

https://510kreport.com/device/K122877 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122877: Range Spinal System, Small Stature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122877

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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