510(k) · Cleared
ClearedSpineselect Polyscrew Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineselect, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 13, 2014 as substantially equivalent to K022623 (Depuyacromed, 2002) and 2 other predicates after a 108-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jan 13, 2014
- Review
- 108 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). No later device cites it as a predicate yet.
- 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 deviceK133066 Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC · 2014
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) | K133066 | Spineselect Polyscrew Pedicle Screw System | Spineselect, LLC | 2014 | — |
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 |
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 2…Page 2 of 2 Predicate Device(s): The SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the Moss Miami System (DePuy Spine) (K022623 and others), Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (1(001319 and others). Performance Standards:… | 2002 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…e(s): The SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the Moss Miami System (DePuy Spine) (K022623 and others), Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (1(001319 and others). Performance Standards: The pre-clinical testing performed includes stati… | 2003 |
| * | K001319 | Xia Spine System HooksSummary page 2…w System is substantially equivalent to the Moss Miami System (DePuy Spine) (K022623 and others), Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (1(001319 and others). Performance Standards: The pre-clinical testing performed includes static and dynamic compression bending and stati… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 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.
- 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. 2014, 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 SpineSelect Polyscrew Pedicle Screw System isintended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw 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 lordlosis); tumor; pseudloarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133066: Spineselect Polyscrew Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133066
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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