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 · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 19, 2020 as substantially equivalent to K113174 (Medtronic Sofamor Danek USA, Inc., 2011) and 3 other predicates after a 28-day review. Its family tree reaches back 19 generations to 2004. 21 later devices descend from it.
- Decided
- Oct 19, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K040583 (2004). 215 ancestors in all, the oldest K781443 (1978). 21 later devices descend from it, 6 citing it directly.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- 1 generation backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
- This deviceK202771 CD Horizon Spinal SystemMedtronic · 2020
- Descendant · cites it directly · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
- Descendant · 2 generations on · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
- Descendant · 3 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK221776 NextGen Pedicle Screw SystemCorelink, LLC · 2022
- Descendant · cites it directly · 1 of its ownK242350 Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc. · 2024
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 4 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 3 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- 1 generation backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
- This deviceK202771 CD Horizon Spinal SystemMedtronic · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · cites it directly12descendants
- K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · 2 generations on8descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on5descendants
- K221776NextGen Pedicle Screw SystemCorelink, LLC · 2022 · 2 generations on2descendants
- K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −4 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −3 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| −1 | K201407 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| 0 (this device) | K202771 | CD Horizon Spinal System | Medtronic | 2020 | — |
| +1 | K211323 | ASTRA Spine System | Spinecraft, LLC | 2021 | — |
| +2 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | — |
| +3 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
| +2 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | — |
| +1 | K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 19 | 0 |
| 2001 | 16 | 0 |
| 2002 | 12 | 0 |
| 2003 | 12 | 0 |
| 2004 | 20 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 12 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 NKB? 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 |
|---|---|---|---|
| * | K113174 | CD Horizon Spinal SystemSummary page 4…21 CFR 888.3050 - Spinal interlaminal fixation orthosis Primary Predicate: CD Horizon Spinal System (K113174, S.E. 11/21/2011) Secondary Predicates: Predicate Devices PASS LP Spinal System (K140738, S.E. 1… | 2011 |
| * | K140738 | Pass LP Spinal SystemSummary page 4…CD Horizon Spinal System (K113174, S.E. 11/21/2011) Secondary Predicates: Predicate Devices PASS LP Spinal System (K140738, S.E. 11/04/2014) CD Horizon™ Spinal System (K042025, S.E. 08/25/2004) CD Horiz… | 2014 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 4…Secondary Predicates: Predicate Devices PASS LP Spinal System (K140738, S.E. 11/04/2014) CD Horizon™ Spinal System (K042025, S.E. 08/25/2004) CD Horizon™ Spinal System (K201407, S.E. 09/10/2020) The pre… | 2004 |
| * | K201407 | CD Horizon™ Spinal SystemSummary page 4…pinal System (K140738, S.E. 11/04/2014) CD Horizon™ Spinal System (K042025, S.E. 08/25/2004) CD Horizon™ Spinal System (K201407, S.E. 09/10/2020) The predicates have not been subject to a design related recall.… | 2020 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211323 | ASTRA Spine System | 2021 | 12 |
| K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | 2024 | 1 |
| K220724 | CD Horizon™ Spinal System and PASS LP™ Spinal System | 2022 | 1 |
| K211057 | LigaPASS® Spinal System, CD Horizon™ Spinal System | 2021 | 1 |
| K213281 | PASS LP™ Spinal System, CD Horizon™ Spinal System | 2022 | 0 |
| K210306 | GII Spinal Fixation System | 2021 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 25 of the 215 ancestors have a recall of any class.
- Of its descendants, K211323 (Spinecraft, LLC, 2021) has gone furthest, with 12 descendants of its own.
- 36 other devices also cite its predicate K113174.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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™ 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 (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 (428 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 (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, the 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, the CD Horizon™ Legacy™ 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, the 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, 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™ 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- Sl) 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 (Tl-Sl) 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.
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 as stated in the FDA summary.
https://510kreport.com/device/K202771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202771: CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202771
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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