510(k) · Cleared
ClearedCD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ 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 Apr 21, 2026 as substantially equivalent to K232141 (Medtronic Sofamor Danek USA, Inc., 2023) and 3 other predicates after an 88-day review. Its family tree reaches back 32 generations to 1984. 1 of the 835 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 21, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 32 generations to K841189 (1984). 834 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 835 devices in this family, counting this one, has a Class I recall.
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations between
- 3 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 2 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
- 1 generation backK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
- This deviceK260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™…Medtronic Sofamor Danek USA, Inc. · 2026
Show all 32 generations
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 31 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 30 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 29 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 26 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 25 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 22 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 21 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 20 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 19 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 18 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 17 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 16 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 15 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 14 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 13 generations backK160955 Tritanium® PL CageStryker · 2016
- 12 generations backK162262 Tritanium® PL CageStryker · 2016
- 11 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 10 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 9 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 6 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 5 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 4 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 3 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 2 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
- 1 generation backK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
- This deviceK260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™…Medtronic Sofamor Danek USA, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −32 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −31 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −30 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −29 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −26 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −25 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −22 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −21 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −20 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −19 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −18 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −17 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −16 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −15 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −14 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −13 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −10 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −9 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −8 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −7 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −6 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −5 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −4 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −3 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −2 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| −1 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| 0 (this device) | K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | — |
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 | 33 | 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 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Summary page 6…y (21 CFR 888.3060) Classification Class II III. Predicate Devices: Primary Predicate: CD Horizon™ Fenestrated Screw Set K232141 (S.E. 08/16/2023) Additional Predicate 1: CD Horizon™ Spinal System K22… | 2023 |
| * | K223494 | CD Horizon Spinal SystemSummary page 6…ew Set K232141 (S.E. 08/16/2023) Additional Predicate 1: CD Horizon™ Spinal System K223494 (S.E. 05/25/2022) Additional Predicate 2: CD Horizon™ Spinal System K22… | 2023 |
| * | K221244 | CD Horizon™ Spinal SystemSummary page 6…System K223494 (S.E. 05/25/2022) Additional Predicate 2: CD Horizon™ Spinal System K221244 (S.E. 01/23/2023) Additional Predicate 3: CD Horizon™ Spinal System K23… | 2022 |
| * | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Summary page 6…System K221244 (S.E. 01/23/2023) Additional Predicate 3: CD Horizon™ Spinal System K233951 (S.E. 03/27/2024) The predicate devices were not subjected to any Recall. IV. Description… | 2024 |
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 42 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 86 of the 834 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
When used without cement, CD Horizon™ Fenestrated Screws including those with or without Titan nanoLOCK™ Surface Technology with micro- and nano-roughened surface textured features (with or without Sextant™ or Longitude™ instrumentation) are 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…
Read the full statement (744 words)
When used without cement, CD Horizon™ Fenestrated Screws including those with or without Titan nanoLOCK™ Surface Technology with micro- and nano-roughened surface textured features (with or without Sextant™ or Longitude™ instrumentation) are 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, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), and/or pseudarthrosis.
Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization and stabilization when used for trauma (e.g. fracture or dislocation) with the usage of bone graft material left to the surgeon’s discretion.
When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The CD Horizon™ Spinal System implants including those with or without Titan nanoLOCK™ Surface Technology with micro- and nano-roughened surface textured features (with or without Sextant™ 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, and/or pseudarthrosis.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ 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 Horizon™ Legacy™ 3.5mm rods and associated components may be used for the 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 Horizon™ 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 Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, and/or pseudarthrosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ 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 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: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, 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.
The CD Horizon™ LigaMAS Head Assembly used with the LigaPASS™ Spinal System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
• Spinal trauma, used in sublaminar, or facet wiring techniques
• Spinal reconstruction surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis;
• Spinal degenerative surgery, as an adjunct to spinal fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260216: CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ 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/K260216
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026