510(k) · Cleared
ClearedNorthStar OCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · NKG Posterior Cervical Screw System
Cleared on Aug 3, 2023 as substantially equivalent to K193615 (SeaSpine Orthopedics Corporation, 2020) and 1 other predicate after a 58-day review. Its family tree reaches back 12 generations to 1985.
- Decided
- Aug 3, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K853033 (1985). 44 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK062934 SierraSeaspine, Inc. · 2006
- 2 generations backK080526 Sierra SystemSeaspine, Inc. · 2008
- 1 generation backK193615 NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK231654 NorthStar OCT SystemSeaspine, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062934 SierraSeaspine, Inc. · 2006
- 2 generations backK080526 Sierra SystemSeaspine, Inc. · 2008
- 1 generation backK193615 NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK231654 NorthStar OCT SystemSeaspine, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| −2 | K080526 | Sierra System | Seaspine, Inc. | 2008 | — |
| −1 | K193615 | NorthStar™ OCT Spinal System | SeaSpine Orthopedics Corporation | 2020 | — |
| 0 (this device) | K231654 | NorthStar OCT System | Seaspine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 NKG? 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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 |
|---|---|---|---|
| * | K193615 | NorthStar™ OCT Spinal SystemSummary page 4…Trade Name(s) Manufacturer Primary Predicate Device SeaSpine K193615 NKG; KWP NorthStar OCT System Orthopedics… | 2020 |
| * | K080526 | Sierra SystemSummary page 4…Corporation Additional Predicate Device(s) SeaSpine K080526 KWP Sierra OCT System Orthopedics… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 44 ancestors has a recall of any class.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Northstar OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1-C?), and upper thoracic spine (T1-T3): • Traumatic spinal fractures and/or traumatic dislocations, • Instability or deformity, • Failed previous fusion (e.g., pseudoarthrosis), • Tumors involving the cervical/thoracic spine, •…
Read the full statement (164 words)
The Northstar OCT System is intended to provide immobilization and stabilization of spinal
segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical
junction, cervical spine (C1-C?), and upper thoracic spine (T1-T3):
• Traumatic spinal fractures and/or traumatic dislocations,
• Instability or deformity,
• Failed previous fusion (e.g., pseudoarthrosis),
• Tumors involving the cervical/thoracic spine,
• Degenerative disease, including intractable radiculopathy and/or myelopathy and neck and/or arm
pain of discogenic origin as confirmed by radiographic studies, and
• Degenerative disease of the facets with instability.
The Northstar OCT System is also intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time period in patients with advanced stage tumors involving the
cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Northstar OCT System can also be linked to other FDA-cleared SeaSpine/Orthofix screw
systems with the use of transitional rods and/or transitional rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231654: NorthStar OCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231654
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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