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, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 24, 2025 as substantially equivalent to K243007 (Medtronic Sofamor Danek USA, Inc., 2024) and 8 other predicates after a 24-day review. Its family tree reaches back 33 generations to 1984. 1 of the 838 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 24, 2025
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 33 generations to K841189 (1984). 837 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 838 devices in this family, counting this one, has a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
- 2 generations backK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
- 1 generation backK243007 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2024
- This deviceK253335 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2025
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 15 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 14 generations backK160955 Tritanium® PL CageStryker · 2016
- 13 generations backK162262 Tritanium® PL CageStryker · 2016
- 12 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 11 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 10 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 7 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 6 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 5 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 4 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 3 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
- 2 generations backK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
- 1 generation backK243007 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2024
- This deviceK253335 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2025
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −15 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −14 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −11 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −10 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −9 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −8 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −7 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −6 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −5 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −4 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −3 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| −2 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| −1 | K243007 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| 0 (this device) | K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 10 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 14 | 0 |
| 2000 | 19 | 0 |
| 2001 | 29 | 0 |
| 2002 | 22 | 0 |
| 2003 | 34 | 0 |
| 2004 | 57 | 0 |
| 2005 | 49 | 0 |
| 2006 | 34 | 0 |
| 2007 | 29 | 0 |
| 2008 | 63 | 1 |
| 2009 | 46 | 0 |
| 2010 | 38 | 0 |
| 2011 | 53 | 0 |
| 2012 | 37 | 0 |
| 2013 | 41 | 0 |
| 2014 | 45 | 0 |
| 2015 | 44 | 0 |
| 2016 | 26 | 0 |
| 2017 | 28 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 5 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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? (9)
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 |
|---|---|---|---|
| * | K243007 | CD Horizon™ Spinal SystemSummary page 5…duct Codes NKB, KWP, and KWQ (888.3070, 888.3060, 888.3050) Primary Predicate: 1. CD Horizon™ Spinal System (K243007, S.E. 9/26/2024) Additional Predicates: 2. CD HORIZON® Spinal System (K223494,… | 2024 |
| * | K223494 | CD Horizon Spinal SystemSummary page 5…1. CD Horizon™ Spinal System (K243007, S.E. 9/26/2024) Additional Predicates: 2. CD HORIZON® Spinal System (K223494, S.E. 11/18/2022) 3. CD HORIZON® Spinal System (K221244, S.E. 04/29/2022) 4. CD… | 2023 |
| * | K221244 | CD Horizon™ Spinal SystemSummary page 5…Additional Predicates: 2. CD HORIZON® Spinal System (K223494, S.E. 11/18/2022) 3. CD HORIZON® Spinal System (K221244, S.E. 04/29/2022) 4. CD Horizon™ Spinal System (K211958, S.E. 06/23/2021) III. Predicate Devices 5. CD… | 2022 |
| * | K211958 | CD Horizon Spinal SystemSummary page 5…System (K223494, S.E. 11/18/2022) 3. CD HORIZON® Spinal System (K221244, S.E. 04/29/2022) 4. CD Horizon™ Spinal System (K211958, S.E. 06/23/2021) III. Predicate Devices 5. CD Horizon™ Spinal System (K210637, S.E. 03/02/2021) 6. CD… | 2021 |
| * | K210637 | CD Horizon™ Spinal SystemSummary page 5…System (K221244, S.E. 04/29/2022) 4. CD Horizon™ Spinal System (K211958, S.E. 06/23/2021) III. Predicate Devices 5. CD Horizon™ Spinal System (K210637, S.E. 03/02/2021) 6. CD HORIZON® Spinal System (K203678, S.E. 12/17/2020) 7. CD… | 2021 |
| * | K203678 | CD HORIZON™ Spinal SystemSummary page 5…System (K211958, S.E. 06/23/2021) III. Predicate Devices 5. CD Horizon™ Spinal System (K210637, S.E. 03/02/2021) 6. CD HORIZON® Spinal System (K203678, S.E. 12/17/2020) 7. CD HORIZON® Spinal System (K173249, S.E. 02/06/2018) 8. CD… | 2021 |
| * | K173249 | CD HORIZON™ Spinal SystemSummary page 5…System (K210637, S.E. 03/02/2021) 6. CD HORIZON® Spinal System (K203678, S.E. 12/17/2020) 7. CD HORIZON® Spinal System (K173249, S.E. 02/06/2018) 8. CD Horizon™ Spinal System (K102555, S.E. 11/19/2010) 9. CD… | 2018 |
| * | K102555 | CD Horizon Spinal SystemSummary page 5…System (K203678, S.E. 12/17/2020) 7. CD HORIZON® Spinal System (K173249, S.E. 02/06/2018) 8. CD Horizon™ Spinal System (K102555, S.E. 11/19/2010) 9. CD Horizon™ Spinal System (K113174, S.E. 10/26/2011) The… | 2010 |
| * | K113174 | CD Horizon Spinal SystemSummary page 5…System (K173249, S.E. 02/06/2018) 8. CD Horizon™ Spinal System (K102555, S.E. 11/19/2010) 9. CD Horizon™ Spinal System (K113174, S.E. 10/26/2011) The predicates have not been subject to a design related recall.… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 86 of the 837 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K243007.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The CD Horizon TM Spinal System with or without SextantT instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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, or lordosis)…
Read the full statement (424 words)
The CD Horizon TM Spinal System with or without SextantT instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon TM Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD HorizonT" Legacy TM 3.5mm 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, CD HorizonT Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HorizonT Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon TM PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD HorizonTM SpireTr 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: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexT Reconstruction System with the VertexT rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTMindications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253335: 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/K253335
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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