510(k) · Cleared
Recalled · Class II · 2024NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 19, 2024 as substantially equivalent to K222110 (SeaSpine Orthopedics Corporation, 2022) and 2 other predicates after a 239-day review. Its family tree reaches back 20 generations to 2004. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 19, 2024
- Review
- 239 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 20 generations to K040583 (2004). 292 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 2 generations backK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- 1 generation backK200381 Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu…SeaSpine Orthopedics Corporation · 2024
- Descendant · cites it directly · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 6 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 5 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 4 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 2 generations backK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- 1 generation backK200381 Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu…SeaSpine Orthopedics Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −6 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −5 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −4 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −3 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| −2 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | — |
| −1 | K200381 | Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2020 | — |
| 0 (this device) | K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal… | SeaSpine Orthopedics Corporation | 2024 | — |
| +1 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
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 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 12 | 0 |
| 1996 | 6 | 0 |
| 1997 | 10 | 0 |
| 1998 | 11 | 0 |
| 1999 | 7 | 0 |
| 2000 | 19 | 0 |
| 2001 | 16 | 0 |
| 2002 | 12 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 26 | 0 |
| 2006 | 18 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K222110 | Mariner RDX SystemSummary page 9…el: Orthopedic Device Panel Primary Predicate Devices: Mariner Pedicle Screw System: – SeaSpine Orthopedics Corporation – K222110 • Mariner Outrigger Revision System • Mariner MIS Pedicle Screw S… | 2022 |
| * | K200381 | Daytona® Small Stature Spinal SystemSummary page 9…• Mariner RDX System Additional Predicate Device: Daytona Small Stature Spinal System – SeaSpine Orthopedics Corporation – K200381, K193224 Reason for 510(k) Submission: SeaSpine is submitting this Traditional 510(k) premarket notification for the addition of… | 2020 |
| * | K193224 | Daytona® Small Stature Growth Rod Conversion SetSummary page 9…• Mariner RDX System Additional Predicate Device: Daytona Small Stature Spinal System – SeaSpine Orthopedics Corporation – K200381, K193224 Reason for 510(k) Submission: SeaSpine is submitting this Traditional 510(k) premarket notification for the addition of MR Condi… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2024 | Class II | Z-0751-2025 | Nonconforming Material/Component | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| Oct 29, 2024 | Class II | Z-0752-2025 | Nonconforming Material/Component | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 7 months on median.
- 42 of the 292 ancestors have a recall of any class.
- Of its descendants, K253420 (SeaSpine Orthopedics Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K222110.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 NewPort Spinal System is intended for posterior, non-cervical pedicle fixation 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 for the following indications: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed…
Read the full statement (905 words)
The NewPort Spinal System is intended for posterior, non-cervical pedicle fixation 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 for the following indications:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
spinal tumor,
pseudoarthrosis, and/or
failed previous fusion.
The Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation 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 indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g., Atoll OCT, Sierra, Malibu, Daytona, and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.
The Daytona Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The extended axial connectors may be used with any cleared Daytona Small Stature Spinal System rod construct. The Daytona Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with staples.
The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
spinal tumor,
pseudoarthrosis, and/or
failed previous fusion.
The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis, and/or
failed previous fusion.
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is 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.
The indications for use are as follows:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
spinal tumor,
pseudarthrosis, and/or
failed previous fusion.
When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems:
The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities:
degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis (i.e., failed previous fusions).
When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
The Mariner Outrigger Revision System is intended to be used with autograft or allograft.
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/K232566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232566: NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232566
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