510(k) · Cleared
Recalled · 2007Radius Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 22, 2006 after a 107-day review. The FDA summary names no predicate by number. 1 of the 461 devices in its family, counting itself, has a Class I recall. 460 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 0
460 later devices descend from it, 8 citing it directly. 1 of the 461 devices in this family, counting this one, has a Class I recall.
- This deviceK062270 Radius Spinal SystemStryker Spine · 2006
- Descendant · cites it directly · 430 of its ownK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- Descendant · cites it directly · 292 of its ownK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- Descendant · 2 generations on · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012
- Descendant · cites it directly · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
- Descendant · cites it directly · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008
Showing 5 of 460 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 460 · See all- K071373Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · cites it directly430descendants
- K083393Xia 3 Spinal SystemStryker Spine · 2009 · cites it directly292descendants
- K113666Xia 3 Spinal SystemStryker Spine · 2012 · 2 generations on251descendants
- K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · cites it directly201descendants
- K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · cites it directly200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062270 | Radius Spinal System | Stryker Spine | 2006 | — |
| +1 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| +1 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| +2 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| +1 | K070631 | Device Modification to Radius Spinal System | Stryker Spine | 2007 | — |
| +1 | K082608 | Radius Spinal System, Vitallium Rod #486613601 | Stryker Spine | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 14 | 0 |
| 2013 | 13 | 0 |
| 2014 | 13 | 0 |
| 2015 | 22 | 0 |
| 2016 | 16 | 0 |
| 2017 | 37 | 0 |
| 2018 | 29 | 0 |
| 2019 | 28 | 0 |
| 2020 | 35 | 0 |
| 2021 | 25 | 1 |
| 2022 | 28 | 0 |
| 2023 | 50 | 0 |
| 2024 | 47 | 0 |
| 2025 | 41 | 0 |
| 2026 | 45 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (460)
See all 4608 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071373 | Stryker Spine Xia Iii Spinal System | 2007 | 430 |
| K083393 | Xia 3 Spinal System | 2009 | 292 |
| K070631 | Device Modification to Radius Spinal System | 2007 | 201 |
| K082608 | Radius Spinal System, Vitallium Rod #486613601 | 2008 | 200 |
| K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | 2009 | 169 |
| K092631 | Mantis Redux Spinal System | 2009 | 110 |
| K101144 | Modification to:Radius Spinal System | 2010 | 90 |
| K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation… | 2013 | 84 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2007 | Not classified | Z-1239-2007 | Other | Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071373 (Stryker Spine, 2007) has gone furthest, with 430 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 RadiusTM Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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/K062270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062270: Radius Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062270
Report an extraction error
Are you the manufacturer?
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