510(k) · Cleared
ClearedMantis Redux 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 Sep 25, 2009 as substantially equivalent to K061813 (Stryker Spine, 2006) and 7 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1995. 110 later devices descend from it.
- Decided
- Sep 25, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 6 generations to K950697 (1995). 43 ancestors in all. 110 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 2 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 1 generation backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- This deviceK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- Descendant · cites it directly · 109 of its ownK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- Descendant · 2 generations on · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
- Descendant · cites it directly · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · 2 generations on · 34 of its ownK111478 Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010 · cites it directly109descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 2 generations on85descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · cites it directly84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
- K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −5 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −2 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −1 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| 0 (this device) | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| +1 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| +2 | K103292 | Trio Trauma Spinal System | Stryker Corporation | 2011 | — |
| +1 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +2 | K111478 | Stryker Spine Power Adaptor (Accessory Instrument) | Stryker Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 18 | 0 |
| 2024 | 17 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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? (8)
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 |
|---|---|---|---|
| * | K061813 | Mantis Spinal System Our reading of the summary gave K061812, FDA’s number for Combi Scan 500 Urine Test Strip Analyzer, Model A93005 (Analyticon Biotechnologies AG). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker Spine MANTIS Spinal System”. | 2006 |
| * | K073151 | Mantis Spinal SystemSummary page 1…[email protected] Date Summary Prepared: August 4, 2009 Predicate Devices ' Stryker Spine MANTIS Spinal System, K061812, K073151; a Stryker Spine Xia® Spinal System, K013823, K043473;… | 2007 |
| * | K013823 | Xia Spinal SystemSummary page 1…vices ' Stryker Spine MANTIS Spinal System, K061812, K073151; a Stryker Spine Xia® Spinal System, K013823, K043473; * Stryker Spine Xia® II Spinal System, K063428;… | 2001 |
| * | K043473 | Modification to Xia Spinal SystemSummary page 1…Stryker Spine MANTIS Spinal System, K061812, K073151; a Stryker Spine Xia® Spinal System, K013823, K043473; * Stryker Spine Xia® II Spinal System, K063428;… | 2005 |
| * | K063428 | Xia Stainless Steel Spinal SystemSummary page 1…a Stryker Spine Xia® Spinal System, K013823, K043473; * Stryker Spine Xia® II Spinal System, K063428; * Stryker Spine Osteonics Spinal System, K951725; and… | 2006 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…* Stryker Spine Xia® II Spinal System, K063428; * Stryker Spine Osteonics Spinal System, K951725; and Stryker Spine Radius® Spinal System, K062270, K082608. MANTIS… | 1995 |
| * | K062270 | Radius Spinal SystemSummary page 1…* Stryker Spine Osteonics Spinal System, K951725; and Stryker Spine Radius® Spinal System, K062270, K082608. MANTIS Spinal System - Line Extension Special 510(k) Premarket N… | 2006 |
| * | K082608 | Radius Spinal System, Vitallium Rod #486613601Summary page 1…* Stryker Spine Osteonics Spinal System, K951725; and Stryker Spine Radius® Spinal System, K062270, K082608. MANTIS Spinal System - Line Extension Special 510(k) Premarket Notificati… | 2008 |
What descends from it? (110)
See all 1103 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 14 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 4 of the 43 ancestors have a recall of any class.
- Of its descendants, K102235 (Stryker Spine, 2010) has gone furthest, with 109 descendants of its own.
- 4 other devices also cite its predicate K061813.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MANTIS ® Spinal System and MANTIS® Redux Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (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 Titanium and Vitallium rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of MANTIS ® Spinal System and MANTIS® Redux Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092631: Mantis Redux 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/K092631
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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