510(k) · Cleared
ClearedVERTICALE® Posterior Spinal Fixation System/VERTICALE® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silony Medical GmbH · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 10, 2018 as substantially equivalent to K131802 (Depuy Spine, A Johnson & Johnson Company, 2013) and 1 other predicate after a 240-day review. Its family tree reaches back 14 generations to 1985. 6 later devices descend from it.
- Decided
- Jan 10, 2018
- Review
- 240 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K853033 (1985). 79 ancestors in all. 6 later devices descend from it, 4 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 backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- This deviceK171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH · 2018
- Descendant · cites it directly · 2 of its ownK201420 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK223096 Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023
- Descendant · cites it directly · 0 of its ownK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 3 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
- Descendant · cites it directly · 0 of its ownK223806 VERTICALE® Triangular Fixation SystemSilony Medical GmbH · 2023
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 backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- This deviceK171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021 · cites it directly2descendants
- K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023 · 2 generations on1descendant
- K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · cites it directly0descendants
- K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023 · 3 generations on0descendants
- K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH · 2023 · cites it directly0descendants
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 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
| −1 | K131802 | Expedium, Viper. Viper 2 Spine System | Depuy Spine, A Johnson & Johnson Company | 2013 | — |
| 0 (this device) | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | Silony Medical GmbH | 2018 | — |
| +1 | K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2021 | — |
| +2 | K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023 | — |
| +1 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +3 | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023 | — |
| +1 | K223806 | VERTICALE® Triangular Fixation System | Silony Medical GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K131802 | Expedium, Viper. Viper 2 Spine SystemSummary page 5…ode: NKB, KWP Device Class: Class Il Classification Panel: Orthopedic K171421 - Page 2 of 4 5. Legally Marketed Predicate Device(s) Primary Predicate K131802, Expedium Spine System,VIPER and VIPER 2 Systems Medos International Sarl. Additional Predicate K092287, NuVasive SpheRx Il (Arm… | 2013 |
| * | K092287 | Nuvasive Spherx II - Pedicle Screw SystemSummary page 5…f 4 5. Legally Marketed Predicate Device(s) Primary Predicate K131802, Expedium Spine System,VIPER and VIPER 2 Systems Medos International Sarl. Additional Predicate K092287, NuVasive SpheRx Il (Armada) — Pedicle Screw System, NuVasive Inc. 6. Indication for Use Statement The VERTICALE® System is int… | 2009 |
What descends from it? (6)
4 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 33 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 79 ancestors have a recall of any class.
- Of its descendants, K201420 (Republic Spine, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K131802.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 VERTICALE® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with…
Read the full statement (224 words)
The VERTICALE® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® and VERTICALE® MIS metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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/K171421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171421
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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