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 May 14, 2018 as substantially equivalent to K122571 (Seaspine, Inc., 2012) and 5 other predicates after a 60-day review. Its family tree reaches back 16 generations to 2004. 12 later devices descend from it.
- Decided
- May 14, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K040583 (2004). 151 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- This deviceK180686 SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2018
- 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 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 1 generation backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- This deviceK180686 SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2018
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 |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −2 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −1 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| 0 (this device) | K180686 | SeaSpine Daytona Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2018 | — |
| +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 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 12 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 18 | 0 |
| 2005 | 17 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K163206 | FDA’s K163206 is SMD-Sr90-DA Radionuclide Brachytherapy Source Our reading of the summary gave K163206, FDA’s number for SMD-Sr90-DA Radionuclide Brachytherapy Source (Salutaris Medical Devices, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SeaSpine Daytona Small Stature Spinal System”. Kept off the family tree. Summary page 4…DICATE Device SeaSpine Daytona SeaSpine Orthopedics K163206 NKB, OSH Small Stature Spinal Corporation… | 2016 |
| * | K122571 | Malibu Spinal System with the Daytona Deformity SystemSummary page 4…l Corporation System ADDITIONAL PREDICATE Devices K122571, K072605, NKB SeaSpine Malibu Spinal SeaSpine Orthopedics K061342, K051942,… | 2012 |
| * | K072605 | Malibu Spinal SystemSummary page 4…Corporation System ADDITIONAL PREDICATE Devices K122571, K072605, NKB SeaSpine Malibu Spinal SeaSpine Orthopedics K061342, K051942,… | 2007 |
| * | K061342 | Malibu Spinal SystemSummary page 4…System ADDITIONAL PREDICATE Devices K122571, K072605, NKB SeaSpine Malibu Spinal SeaSpine Orthopedics K061342, K051942, System Corporation K051663… | 2006 |
| * | K051942 | Malibu Spinal SystemSummary page 4…System ADDITIONAL PREDICATE Devices K122571, K072605, NKB SeaSpine Malibu Spinal SeaSpine Orthopedics K061342, K051942, System Corporation K051663… | 2005 |
| * | K051663 | Malibu Spinal SystemSummary page 4…SeaSpine Malibu Spinal SeaSpine Orthopedics K061342, K051942, System Corporation K051663 CD Horizon Spinal Medtronic Sofamor K140276 NKB, OSH… | 2005 |
| * | K140276 | CD Horizon Spinal SystemSummary page 4…System Corporation K051663 CD Horizon Spinal Medtronic Sofamor K140276 NKB, OSH System Danek… | 2014 |
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 14 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 16 of the 151 ancestors have a recall of any class.
- Of its descendants, K183639 (SeaSpine Orthopedics Corporation, 2019) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K122571.
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 SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical 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 (272 words)
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical 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 SeaSpine 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 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 SeaSpine’s Atoll OCT Spinal System, Sierra Spinal System,
or Malibu Spinal System using the rod connectors. Refer to the Atoll, Sierra, or Malibu System’s Package Insert for the
indications for use for those systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180686: 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/K180686
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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