510(k) · Cleared
ClearedSwedge™ Pedicle Screw Fixation System Bezier Rod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Resources, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 13, 2026 as substantially equivalent to K230482 (Spinal Resources, Inc., 2023) after a 161-day review. Its family tree reaches back 12 generations to 2004.
- Decided
- Jan 13, 2026
- Review
- 161 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K040583 (2004). 115 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations between
- 3 generations backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- 2 generations backK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
- 1 generation backK230482 Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc. · 2023
- This deviceK252461 Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 3 generations backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- 2 generations backK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
- 1 generation backK230482 Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc. · 2023
- This deviceK252461 Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −9 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −7 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −4 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −3 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
| −2 | K121342 | Xia 4.5 Spinal System | Stryker Corp. | 2012 | — |
| −1 | K230482 | Swedge™ Pedicle Screw Fixation System | Spinal Resources, Inc. | 2023 | — |
| 0 (this device) | K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K230482 | Swedge™ Pedicle Screw Fixation SystemSummary page 6…zes • Sterilization • Biocompatibility Primary Predicate Device 510(k) Number Trade or Proprietary or Model Name Manufacturer Product Code K230482 Swedge™ Pedicle Screw Fixation System Spinal Resources, Inc. NKB PERFORMANCE DATA The Swedge™ Pedicle Screw Fixation S… | 2023 |
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 22 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 16 of the 115 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Swedge TM Pedicle Screw Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or…
Read the full statement (307 words)
The Swedge TM Pedicle Screw Fixation System is intended to provide immobilization and stabilization of
spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute
and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis
with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e.
scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis and failed previous fusion.
The Swedge ™ Bezier rods may be used with compatible systems that use 4.75, 5.0, 5.5, and 6.0mm
posterior rods made from either titanium alloy or cobalt chrome alloys. When connected to compatible
systems, the Swedge TM Bezier rods are intended to provide immobilization and stabilization of spinal
segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute
and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease
defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic
studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture,
dislocation, deformities or curvatures (i.e., scoliosis and/or kyphosis), spinal tumor, pseudoarthrosis, and
failed previous fusion.
Please refer to the additional information section in the Instructions for Use on compatible pedicle screw
system rod requirements.
The Swedge TM Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for
the following indications: DDD ( degenerative disc disease) 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. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e.
fracture or dislocation); spinal stenosis; deformities or 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/K252461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252461: Swedge™ Pedicle Screw Fixation System Bezier Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252461
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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