510(k) Report

510(k) · Cleared

Cleared

Mariner Outrigger Revision System

K183639510(k) TraditionalCleared May 23, 2019148-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

SeaSpine Orthopedics Corporation · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 23, 2019 as substantially equivalent to K173882 (SeaSpine Orthopedics Corporation, 2018) and 4 other predicates after a 148-day review. Its family tree reaches back 19 generations to 2004. 8 later devices descend from it.

Decided
May 23, 2019
Review
148 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
5

Its longest line of descent runs back 19 generations to K040583 (2004). 333 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 2 other ancestors2017: 2 other ancestors2016: 3 other ancestors2015: 3 other ancestors2012: 8 other ancestors2011: 10 other ancestors2008: 18 other ancestors2007: 9 other ancestors2006: 19 other ancestors2005: 24 other ancestors2013: 3 other ancestors2010: 12 other ancestors2009: 11 other ancestors2004: 29 other ancestors2003: 22 other ancestors2002: 23 other ancestors2001: 23 other ancestors2000: 20 other ancestors1999: 11 other ancestors1995: 9 other ancestors1998: 17 other ancestors1997: 9 other ancestors1996: 9 other ancestors1994: 5 other ancestors1978: 1 other ancestor1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1985: 1 other ancestor1984: 1 other ancestor2023: 2 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×3: 3 generations cleared close together, K131321 (2013), K132471 (2013), K140276 (2014) K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K152632 · XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory · Stryker Corporation · 2015K163604 · SeaSpine® Daytona® Small Stature Spinal System · SeaSpine Orthopedics Corporation · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 12 other ancestors3 generations back: 38 other ancestors4 generations back: 65 other ancestors5 generations back: 77 other ancestors6 generations back: 67 other ancestors7 generations back: 39 other ancestors8 generations back: 8 other ancestors9 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K163604 · SeaSpine® Daytona® Small Stature Spinal System · SeaSpine Orthopedics Corporation · 2017K152632 · XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory · Stryker Corporation · 2015K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K140276 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2014K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  4. 2 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  5. 1 generation backK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
  6. This deviceK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019
  7. Descendant · cites it directly · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
  8. Descendant · 2 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  9. Descendant · 2 generations on · 3 of its ownK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021 · Recalled
  10. Descendant · 2 generations on · 2 of its ownK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  11. Descendant · cites it directly · 1 of its ownK231069 PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2023
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 5 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 4 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 2 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  19. 1 generation backK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
  20. This deviceK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2020: 22021: 12022: 12023: 22024: 12026: 1
2020high 2 (2020) · low 0 (2025)2026

Most influential descendants

Showing 5 of 8 · See all
  • K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · cites it directly7descendants
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 2 generations on4descendants
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 2021 · 2 generations on3descendants
  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022 · 2 generations on2descendants
  • K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2023 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−3K142381Xia 3 Spinal SystemStryker Corp.2014—
−2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—
−1K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation2017—
0 (this device)K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation2019—
+1K193396PERLA® TL posterior osteosynthesis systemSpineart20202
+2K203222PERLA TL Posterior Osteosynthesis SystemSpineart2020—
+2K203506PERLA® TL posterior osteosynthesis systemSpineart20212
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart2022—
+1K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199450
199590
199690
199790
1998170
1999110
2000200
2001230
2002230
2003220
2004290
2005240
2006190
200790
2008180
2009110
2010120
2011100
201280
201330
201530
201630
201720
201820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202110
202210
202320
202410
202610
FIG. 1 — Lineage of K183639, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K173882SeaSpine Mariner Pedicle Screw System
Summary page 4
…thosis I NKB Legally Marketed Predicate Devices 510(k) Number \ Product Code \ Trade Name \ Manufacturer PRIMARY PREDICATE Device Mariner Pedicle SeaSpine Orthopedics K173882 NKB Screw System Corporation ADDITIONAL PREDICATE Device K163604, NKB, OSH, Daytona Small SeaSpine Orthopedics K180686 KWP, KWQ S…
SeaSpine Orthopedics Corporation20181
*K163604SeaSpine® Daytona® Small Stature Spinal System
Summary page 4
…\ Product Code \ Trade Name \ Manufacturer PRIMARY PREDICATE Device Mariner Pedicle SeaSpine Orthopedics K173882 NKB Screw System Corporation ADDITIONAL PREDICATE Device K163604, NKB, OSH, Daytona Small SeaSpine Orthopedics K180686 KWP, KWQ Stature System Corporation K170647, NKG, KWP, K172194 NKB. KWQ Con…
SeaSpine Orthopedics Corporation2017—
*K180686SeaSpine Daytona Small Stature Spinal System
Summary page 4
…DICATE Device Mariner Pedicle SeaSpine Orthopedics K173882 NKB Screw System Corporation ADDITIONAL PREDICATE Device K163604, NKB, OSH, Daytona Small SeaSpine Orthopedics K180686 KWP, KWQ Stature System Corporation K170647, NKG, KWP, K172194 NKB. KWQ Connector System Orthofix Inc. K183639 -…
SeaSpine Orthopedics Corporation2018—
*K170647Connector System
Summary page 4
…pedics K173882 NKB Screw System Corporation ADDITIONAL PREDICATE Device K163604, NKB, OSH, Daytona Small SeaSpine Orthopedics K180686 KWP, KWQ Stature System Corporation K170647, NKG, KWP, K172194 NKB. KWQ Connector System Orthofix Inc. K183639 - Page 2 of 3 Device Description The Mariner…
Orthofix, Inc.2017—
*K172194Connector System
Summary page 4
…Screw System Corporation ADDITIONAL PREDICATE Device K163604, NKB, OSH, Daytona Small SeaSpine Orthopedics K180686 KWP, KWQ Stature System Corporation K170647, NKG, KWP, K172194 NKB. KWQ Connector System Orthofix Inc. K183639 - Page 2 of 3 Device Description The Mariner Outrigger Revision…
Orthofix, Inc.20172

Also cleared against K173882: 2 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193396PERLA® TL posterior osteosynthesis systemSpineart20207
K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231

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 15 years and passes through 7 companies; a new generation was cleared every 5 months on median.
  • 44 of the 333 ancestors have a recall of any class.
  • Of its descendants, K193396 (Spineart, 2020) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K173882.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

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…

Read the full statement (163 words)

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,

pseudarthrosis (i.e., failed previous fusion)

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.

Also cleared against K173882

2 other devices cite the same predicate.

  • K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2023
  • K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021

More from SeaSpine Orthopedics Corporation

67 FDA decisions under this applicant name. See the company

  • K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody…SeaSpine Orthopedics Corporation · 2026
  • K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation · 20251 recall
  • K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
  • K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 20242 recalls
  • K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody…SeaSpine Orthopedics Corporation · 2024

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K183639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183639: Mariner Outrigger Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183639

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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