510(k) · Cleared
ClearedDevice Modification to Radius 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 Jul 13, 2007 as substantially equivalent to K062270 (Stryker Spine, 2006) and 5 other predicates after a 128-day review. Its family tree reaches back 4 generations to 1999. 201 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 128 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K984251 (1999). 16 ancestors in all, the oldest K951725 (1995). 201 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK984251 Xia Spine SystemHowmedica, Inc. · 1999
- 3 generations backK012027 Modification to Xia Spine SystemHowmedica Osteonics · 2001
- 2 generations backK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- 1 generation backK052181 Modification to Xia Spinal SystemStryker Spine · 2005
- This deviceK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
- Descendant · cites it directly · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008
- Descendant · 2 generations on · 169 of its ownK091291 Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009
- Descendant · 3 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 110 of its ownK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- Descendant · 3 generations on · 109 of its ownK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
Showing 5 of 201 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 201 · See all- K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · cites it directly200descendants
- K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009 · 2 generations on169descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 3 generations on111descendants
- K092631Mantis Redux Spinal SystemStryker Spine · 2009 · 2 generations on110descendants
- K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010 · 3 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984251 | Xia Spine System | Howmedica, Inc. | 1999 | — |
| −3 | K012027 | Modification to Xia Spine System | Howmedica Osteonics | 2001 | — |
| −2 | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| −1 | K052181 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| 0 (this device) | K070631 | Device Modification to Radius Spinal System | Stryker Spine | 2007 | — |
| +1 | K082608 | Radius Spinal System, Vitallium Rod #486613601 | Stryker Spine | 2008 | — |
| +2 | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | Stryker Spine | 2009 | — |
| +3 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| +3 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 7 | 0 |
| 2022 | 14 | 0 |
| 2023 | 26 | 0 |
| 2024 | 25 | 0 |
| 2025 | 18 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K062270 | Radius Spinal SystemSummary page 2…ystem Special 510(k) Premarket Notification Predicate Devices * Stryker Spine RadiusTM Spinal System, K062270 * Stryker Spine Xia® Spinal System, K043473,… | 2006 |
| * | K043473 | Modification to Xia Spinal SystemSummary page 2…vices * Stryker Spine RadiusTM Spinal System, K062270 * Stryker Spine Xia® Spinal System, K043473, K012870, K031893, K052181, K060631.… | 2005 |
| * | K012870 | Xia Stainless Steel SystemSummary page 2…M Spinal System, K062270 * Stryker Spine Xia® Spinal System, K043473, K012870, K031893, K052181, K060631. * Medtronic Sofamor Danek CD Horizon® Legacy TM… | 2001 |
| * | K031893 | Xia Spinal System and Xia Stainless Steel SystemSummary page 2…System, K062270 * Stryker Spine Xia® Spinal System, K043473, K012870, K031893, K052181, K060631. * Medtronic Sofamor Danek CD Horizon® Legacy TM… | 2003 |
| * | K052181 | Modification to Xia Spinal SystemSummary page 2…062270 * Stryker Spine Xia® Spinal System, K043473, K012870, K031893, K052181, K060631. * Medtronic Sofamor Danek CD Horizon® Legacy TM… | 2005 |
| Kept off the family tree | K060631 | FDA’s K060631 is Biograph 64 and Biograph 40 Our reading of the summary gave K060631, FDA’s number for Biograph 64 and Biograph 40 (Siemens Medical Solutions USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Spine Xia® Spinal System”. Kept off the family tree. Summary page 2…* Stryker Spine Xia® Spinal System, K043473, K012870, K031893, K052181, K060631. * Medtronic Sofamor Danek CD Horizon® Legacy TM… | 2006 |
| * | K020709 | Modification to CD Horizon Spinal SystemSummary page 2…181, K060631. * Medtronic Sofamor Danek CD Horizon® Legacy TM System, K020709. Description of Device Modification This 510(k) is intended to introduce an extension to the… | 2002 |
What descends from it? (201)
See all 2012 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 8 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K082608 (Stryker Spine, 2008) has gone furthest, with 200 descendants of its own.
- 7 other devices also cite its predicate K062270.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 RadiusTM Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the RadiusTM Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: · Degenerative disc disease (DDD) (defined as back…
Read the full statement (132 words)
The RadiusTM Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the RadiusTM Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· 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.
The RadiusTM Spinal System can also be linked to the Xia® Titanium Spinal System via the 05.5 mm to 06.0 mm Radius T rod-to-rod connector
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070631: Device Modification to Radius 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/K070631
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