510(k) · Cleared
ClearedRepublic Spine Dark Star Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Republic Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 5, 2021 as substantially equivalent to K181495 (Republic Spine, LLC, 2018) and 4 other predicates after a 280-day review. Its family tree reaches back 18 generations to 2004. 2 later devices descend from it.
- Decided
- Mar 5, 2021
- Review
- 280 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K040583 (2004). 295 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 2 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- 1 generation backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- This deviceK201420 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
- Descendant · cites it directly · 1 of its ownK223096 Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 5 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 4 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 3 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 2 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- 1 generation backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- This deviceK201420 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −5 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −4 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −3 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| −2 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| −1 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… | Orthofix, Inc. | 2018 | — |
| 0 (this device) | K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2021 | — |
| +1 | K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023 | — |
| +2 | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 18 | 0 |
| 2001 | 22 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 30 | 0 |
| 2005 | 20 | 0 |
| 2006 | 18 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 8 | 0 |
| 2010 | 12 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K181495 | Republic Spine Dark Star Spinal SystemSummary page 4…Name Thoracolumbosacral pedicle screw system, Spinal interlaminal fixation orthosis Product Code NKB, KWP Primary Predicate K181495, Republic Spine Dark Star Spinal System Device Additional K193100, OrthoPediatrics, Corp. Predicate Devices K180… | 2018 |
| * | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemSummary page 4…pinal interlaminal fixation orthosis Product Code NKB, KWP Primary Predicate K181495, Republic Spine Dark Star Spinal System Device Additional K193100, OrthoPediatrics, Corp. Predicate Devices K180179, K141186, Orthofix Inc K171421, VERTICALE® Posterio… | 2020 |
| * | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Summary page 4…NKB, KWP Primary Predicate K181495, Republic Spine Dark Star Spinal System Device Additional K193100, OrthoPediatrics, Corp. Predicate Devices K180179, K141186, Orthofix Inc K171421, VERTICALE® Posterior Spinal Fixation System Device Description The Re… | 2018 |
| * | K141186 | Firebird Spinal Fixation SystemSummary page 4…KWP Primary Predicate K181495, Republic Spine Dark Star Spinal System Device Additional K193100, OrthoPediatrics, Corp. Predicate Devices K180179, K141186, Orthofix Inc K171421, VERTICALE® Posterior Spinal Fixation System Device Description The Republic Sp… | 2015 |
| * | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSummary page 4…Spine Dark Star Spinal System Device Additional K193100, OrthoPediatrics, Corp. Predicate Devices K180179, K141186, Orthofix Inc K171421, VERTICALE® Posterior Spinal Fixation System Device Description The Republic Spine Dark Star Spinal System is a multi-compon… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223096 | Dark Star Deformity Pedicle Screw System | 2023 | 1 |
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 17 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 38 of the 295 ancestors have a recall of any class.
- Of its descendants, K223096 (Republic Spine, LLC, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the…
Read the full statement (103 words)
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• 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;
• Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis; and
• Failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201420: Republic Spine Dark Star 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/K201420
Report an extraction error
Are you the manufacturer?
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