510(k) · Cleared
ClearedSeneka I Polyscrew Pedicle Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senecka Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 30, 2015 as substantially equivalent to K022623 (Depuyacromed, 2002) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Sep 30, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K955348 (1996). 12 ancestors in all, the oldest K933881 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 3 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- 2 generations backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- 1 generation backK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
- This deviceK151849 Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine · 2015
- Descendant · cites it directly · 0 of its ownK153525 Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine · 2016
Most influential descendants
Showing 1 of 1 · See all- K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −3 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| −2 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| −1 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
| 0 (this device) | K151849 | Seneka I Polyscrew Pedicle Fixation System | Senecka Spine | 2015 | — |
| +1 | K153525 | Seneka II Polyscrew Pedicle Fixation System | Senecka Spine | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 4…2371-13. Predicate Device(s): The Seneka I Polyscrew Pedicle Fixation System is substantially the primary predicate device which is the Moss Miami System (DePuy Spine) (K022623). Additional predicate devices include Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (K001319). === Page… | 2002 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 4…em is substantially the primary predicate device which is the Moss Miami System (DePuy Spine) (K022623). Additional predicate devices include Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (K001319).… | 2003 |
| * | K001319 | Xia Spine System HooksSummary page 4…device which is the Moss Miami System (DePuy Spine) (K022623). Additional predicate devices include Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (K001319). K151849 - Page 2 of 2 Perform… | 2000 |
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 |
|---|---|---|---|
| K153525 | Seneka II Polyscrew Pedicle Fixation System | 2016 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K153525 (Senecka Spine, 2016) has gone furthest, with 0 descendants of its own.
- 28 other devices also cite its predicate K022623.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Seneka I Polyscrew Pedicle Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151849: Seneka I Polyscrew Pedicle Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151849
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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