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 Jul 25, 2018 as substantially equivalent to K150283 (Republic Spine, LLC, 2015) after a 49-day review. Its family tree reaches back 11 generations to 1985. 3 later devices descend from it.
- Decided
- Jul 25, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K853033 (1985). 64 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- 1 generation backK150283 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2015
- This deviceK181495 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 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 · 3 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- 1 generation backK150283 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2015
- This deviceK181495 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2018
Most influential descendants
Showing 3 of 3 · 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
- K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K102204 | Choice Spine Starfire Pedicle Screw System | Choicespine, LP | 2010 | — |
| −1 | K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015 | — |
| 0 (this device) | K181495 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 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 | — |
| +3 | 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 |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K150283 | Republic Spine Dark Star Spinal SystemSummary page 4…sis); e Tumor; e Pseudoarthrosis; and ¢ Failed previous fusion PREDICATE DEVICE Primary Predicate Device 510k Trade or Proprietary or Model Name Number Manufacturer K150283 Dark Star Spinal System Republic Spine K181495 - Page 2 of 3 NON-CLINICAL PERFORMANCE DATA The predicate Republi… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201420 | Republic Spine Dark Star Spinal System | 2021 | 2 |
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 2.1 years on median.
- 8 of the 64 ancestors have a recall of any class.
- Of its descendants, K201420 (Republic Spine, LLC, 2021) has gone furthest, with 2 descendants 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. 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 Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid 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 (T1-S1):
Degenerative Disc Disease (DDD);
Spondylolisthesis;
Trauma (i.e. fracture or dislocation);
Spinal stenosis;
Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
Tumor;
Pseudoarthrosis; and
Failed previous fusion
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/K181495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181495: 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/K181495
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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