510(k) · Cleared
ClearedRange Spinal System
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 May 9, 2013 as substantially equivalent to K070229 (K2m, Inc., 2007) and 10 other predicates after a 27-day review. Its family tree reaches back 14 generations to 1985. 34 later devices descend from it.
- Decided
- May 9, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 14 generations to K853033 (1985). 124 ancestors in all, the oldest K841189 (1984). 34 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- This deviceK131030 Range Spinal SystemK2m, 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 · 4 generations on · 12 of its ownK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- This deviceK131030 Range Spinal SystemK2m, 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 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −1 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| 0 (this device) | K131030 | Range Spinal System | 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 | — |
| +4 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 13 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 13 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 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? (11)
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…WP. MNH, 051- Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS,… | 2007 |
| * | K072914 | Natural Bridge LP Transverse ConnectorsSummary page 1…051- Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS, Dual -Ope… | 2008 |
| * | K080792 | K2M Cocr RodSummary page 1…egulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS, Dual -Opening, Sm… | 2008 |
| * | K081381 | Range Spinal System, Large Denali Screws Our reading of the summary gave K081301, 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”. | 2008 |
| * | K100851 | Range Spinal SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K0229… | 2010 |
| * | K112037 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K112920 | Range Spinal System (Mesa and Denali) | 2011 |
| * | K120099 | Range Spinal System (Mesa and Denali)Summary page 1…e or legally marketed devices which are substantially equivalent * K2M Range Spinal System (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K022949) 4. Description of the device:… | 2012 |
| * | K121016 | Range Spinal System (Mesa and Denali) Our reading of the summary gave K121061, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “K2M Range Spinal System”. | 2012 |
| * | K120899 | Range Spinal System, Unit RodSummary page 1…ted devices which are substantially equivalent * K2M Range Spinal System (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K022949) 4. Description of the device: The Range Spi… | 2012 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…m (K070229, K072914,K080792, K081301, K100851, KI 12037, KI 12920. K120099, K121061. K 120899) * Synthes USS, Click'X, VAS, Dual -Opening, Small Stature (K022949) 4. Description of the device: The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar… | 2003 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 124 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 L5-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 ARI 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/K131030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131030: Range 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/K131030
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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