510(k) · Decided
DecidedRange Spinal System, Small Strature Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Cleared on Feb 13, 2013 as substantially equivalent to K070229 (K2m, Inc., 2007) and 2 other predicates after a 99-day review. Its family tree reaches back 13 generations to 2004. 34 later devices descend from it.
- Decided
- Feb 13, 2013
- Review
- 99 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K040583 (2004). 184 ancestors in all, the oldest K781443 (1978). 34 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations between
- 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 1 generation backK121630 Range Spinal SystemK2m, Inc. · 2012
- This deviceK123412 Range Spinal System, Small Strature ComponentsK2m, Inc. · 2013
- Descendant · cites it directly · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · 3 generations on · 13 of its ownK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
Show all 13 generations
- Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 1 generation backK121630 Range Spinal SystemK2m, Inc. · 2012
- This deviceK123412 Range Spinal System, Small Strature ComponentsK2m, Inc. · 2013
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −10 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −8 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −7 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −5 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −4 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −3 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −2 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −1 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| 0 (this device) | K123412 | Range Spinal System, Small Strature Components | K2m, Inc. | 2013 | — |
| +1 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +2 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +3 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +3 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
| +1 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 3 | 0 |
| 2000 | 15 | 0 |
| 2001 | 16 | 0 |
| 2002 | 10 | 0 |
| 2003 | 12 | 0 |
| 2004 | 24 | 0 |
| 2005 | 19 | 0 |
| 2006 | 13 | 0 |
| 2007 | 5 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K070229 | Range Spinal SystemSummary page 1…MNH, OSI- Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: K2M Range Spinal System (K070229, K120099, K12 1630) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, posteri… | 2007 |
| * | K120099 | Range Spinal System (Mesa and Denali)Summary page 1…Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: K2M Range Spinal System (K070229, K120099, K12 1630) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, posterior (thora… | 2012 |
| * | K121630 | Range Spinal SystemSummary page 1…tory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent: K2M Range Spinal System (K070229, K120099, K12 1630) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar… | 2012 |
What descends from it? (34)
See all 342 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 9 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 19 of the 184 ancestors have a recall of any class.
- Of its descendants, K133944 (K2m, Inc., 2014) has gone furthest, with 33 descendants of its own.
- 23 other devices also cite its predicate K070229.
How does its category compare?
All OSH devicesOSH 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OSH
82in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSH
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSH
3in 2025
MAUDE reports naming product code OSH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 76 | 0 | 1 |
| 2013 | 14 | 82 | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 1 | 4 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
RANGE /DENALI, MESA and SMALL STATURE and ARI 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 ARI 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 ART 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/K123412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123412: Range Spinal System, Small Strature Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123412
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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