510(k) · Cleared
ClearedCD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Cleared on Jun 5, 2013 as substantially equivalent to K113174 (Medtronic Sofamor Danek USA, Inc., 2011) and 4 other predicates after a 28-day review. Its family tree reaches back 13 generations to 2004. 195 later devices descend from it.
- Decided
- Jun 5, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K040583 (2004). 82 ancestors in all, the oldest K841189 (1984). 195 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 backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- Descendant · cites it directly · 132 of its ownK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 100 of its ownK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- Descendant · 2 generations on · 94 of its ownK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 2 generations on · 85 of its ownK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- Descendant · 3 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
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 backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
Showing 5 of 195 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 195 · See all- K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly132descendants
- K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013 · cites it directly100descendants
- K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on94descendants
- K140276CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014 · 2 generations on85descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 3 generations on83descendants
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 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| 0 (this device) | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| +1 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| +2 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +2 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| +3 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 14 | 0 |
| 2018 | 10 | 0 |
| 2019 | 10 | 0 |
| 2020 | 11 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 30 | 0 |
| 2024 | 28 | 0 |
| 2025 | 24 | 0 |
| 2026 | 24 | 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? (5)
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 |
|---|---|---|---|
| * | K113174 | CD Horizon Spinal SystemSummary page 3…res, materials, labeling, and indications for use of the subject devices are substantially equivalent to devices previously cleared as part of CD HORIZON® Spinal System (K113174, SE Nov 21, 2011; K121680, SE Jul 5, 2012; K043488, SE Mar 21, 2005; K040962, SE May 14, 2004; K042025, SE Aug 25, 2004). Brief… | 2011 |
| * | K121680 | CD Horizon Spinal SystemSummary page 3…and indications for use of the subject devices are substantially equivalent to devices previously cleared as part of CD HORIZON® Spinal System (K113174, SE Nov 21, 2011; K121680, SE Jul 5, 2012; K043488, SE Mar 21, 2005; K040962, SE May 14, 2004; K042025, SE Aug 25, 2004). Brief Discussion of the Non-Clin… | 2012 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 3…f the subject devices are substantially equivalent to devices previously cleared as part of CD HORIZON® Spinal System (K113174, SE Nov 21, 2011; K121680, SE Jul 5, 2012; K043488, SE Mar 21, 2005; K040962, SE May 14, 2004; K042025, SE Aug 25, 2004). Brief Discussion of the Non-Clinical Tests Submitted A r… | 2005 |
| * | K040962 | Modification to CD Horizon Spinal SystemSummary page 3…substantially equivalent to devices previously cleared as part of CD HORIZON® Spinal System (K113174, SE Nov 21, 2011; K121680, SE Jul 5, 2012; K043488, SE Mar 21, 2005; K040962, SE May 14, 2004; K042025, SE Aug 25, 2004). Brief Discussion of the Non-Clinical Tests Submitted A risk analysis of the device… | 2004 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 3…o devices previously cleared as part of CD HORIZON® Spinal System (K113174, SE Nov 21, 2011; K121680, SE Jul 5, 2012; K043488, SE Mar 21, 2005; K040962, SE May 14, 2004; K042025, SE Aug 25, 2004). Brief Discussion of the Non-Clinical Tests Submitted A risk analysis of the device modifications was complet… | 2004 |
What descends from it? (195)
See all 1952 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.
- 11 of the 82 ancestors have a recall of any class.
- Of its descendants, K132471 (Medtronic Sofamor Danek USA, Inc., 2013) has gone furthest, with 132 descendants of its own.
- 36 other devices also cite its predicate K113174.
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?
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, 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)…
Read the full statement (326 words)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, 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 CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131321: CD Horizon 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/K131321
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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