510(k) · Cleared
ClearedSeaSpine® Daytona® Small Stature Spinal 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 Mar 9, 2017 as substantially equivalent to K161535 (SeaSpine Orthopedics Corporation, 2016) and 6 other predicates after a 78-day review. Its family tree reaches back 18 generations to 2004. 12 later devices descend from it.
- Decided
- Mar 9, 2017
- Review
- 78 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 18 generations to K040583 (2004). 212 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 1 generation backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- This deviceK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 8 of its ownK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- Descendant · 3 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
- Descendant · 3 generations on · 3 of its ownK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021 · Recalled
- Descendant · 3 generations on · 2 of its ownK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
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 backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 4 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 1 generation backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- This deviceK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019 · cites it directly8descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · 2 generations on7descendants
- K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 3 generations on4descendants
- K203506PERLA® TL posterior osteosynthesis systemSpineart · 2021 · 3 generations on3descendants
- K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022 · 3 generations on2descendants
View 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 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −4 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −1 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| 0 (this device) | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| +3 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | — |
| +3 | K203506 | PERLA® TL posterior osteosynthesis system | Spineart | 2021 | 2 |
| +3 | K213470 | PERLA® TL Posterior Osteosynthesis System | Spineart | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 20 | 0 |
| 2005 | 22 | 0 |
| 2006 | 15 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K161535 | SeaSpine® NewPort™ Spinal SystemSummary page 4…Trade Name Manufacturer PRIMARY PREDICATE Device NKB SeaSpine® Orthopedics K161535 MNH Newport® Spinal System Corporation MNI… | 2016 |
| * | K122571 | Malibu Spinal System with the Daytona Deformity SystemSummary page 4…cs K161535 MNH Newport® Spinal System Corporation MNI ADDITIONAL PREDICATE Devices K122571 K072605 NKB SeaSpine® Orthopedics K061342 MNH Mali… | 2012 |
| * | K072605 | Malibu Spinal SystemSummary page 4…35 MNH Newport® Spinal System Corporation MNI ADDITIONAL PREDICATE Devices K122571 K072605 NKB SeaSpine® Orthopedics K061342 MNH Malibu® Spin… | 2007 |
| * | K061342 | Malibu Spinal SystemSummary page 4…Corporation MNI ADDITIONAL PREDICATE Devices K122571 K072605 NKB SeaSpine® Orthopedics K061342 MNH Malibu® Spinal System Corporation K051942 MNI… | 2006 |
| * | K051942 | Malibu Spinal SystemSummary page 4…SeaSpine® Orthopedics K061342 MNH Malibu® Spinal System Corporation K051942 MNI K051663 NKB OSH MNH K152632 XIA® 4.5 Spinal System St… | 2005 |
| * | K051663 | Malibu Spinal SystemSummary page 4…SeaSpine® Orthopedics K061342 MNH Malibu® Spinal System Corporation K051942 MNI K051663 NKB OSH MNH K152632 XIA® 4.5 Spinal System Stryker® Corporatio… | 2005 |
| * | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessorySummary page 4…Malibu® Spinal System Corporation K051942 MNI K051663 NKB OSH MNH K152632 XIA® 4.5 Spinal System Stryker® Corporation MNI KWP KWQ === P… | 2015 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 28 of the 212 ancestors have a recall of any class.
- Of its descendants, K183639 (SeaSpine Orthopedics Corporation, 2019) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K161535.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SeaSpine 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…
Read the full statement (239 words)
The SeaSpine 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; Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion; 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.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163604: SeaSpine® Daytona® Small Stature 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/K163604
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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