510(k) · Cleared
ClearedMantis Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 6, 2007 as substantially equivalent to K061813 (Stryker Spine, 2006) and 5 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1995. 111 later devices descend from it.
- Decided
- Dec 6, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K950697 (1995). 21 ancestors in all. 111 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 4 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 1 generation backK061813 Mantis Spinal SystemStryker Spine · 2006 · Recalled
- This deviceK073151 Mantis Spinal SystemStryker Corp. · 2007
- Descendant · cites it directly · 110 of its ownK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- Descendant · 2 generations on · 109 of its ownK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- Descendant · 3 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
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K092631Mantis Redux Spinal SystemStryker Spine · 2009 · cites it directly110descendants
- K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010 · 2 generations on109descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 3 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −4 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −1 | K061813 | Mantis Spinal System | Stryker Spine | 2006 | 2 |
| 0 (this device) | K073151 | Mantis Spinal System | Stryker Corp. | 2007 | — |
| +1 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| +2 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| +3 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (6)
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 SystemSummary page 1…October 18, 2007 Predicate Device Identification The predicate device is the existing Stryker Spine MANTIS Spinal System (Cleared through 5 10(k) #K061813), Stryker Spine Xia® Titanium Spinal System (cleared through 5 10(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Oste… | 2006 |
| * | K013823 | Xia Spinal SystemSummary page 1…edicate device is the existing Stryker Spine MANTIS Spinal System (Cleared through 5 10(k) #K061813), Stryker Spine Xia® Titanium Spinal System (cleared through 5 10(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Osteonics Spinal System (cleared through 5 10(k) #K951725). Description of Device… | 2001 |
| * | K043473 | Modification to Xia Spinal SystemSummary page 1…vice is the existing Stryker Spine MANTIS Spinal System (Cleared through 5 10(k) #K061813), Stryker Spine Xia® Titanium Spinal System (cleared through 5 10(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Osteonics Spinal System (cleared through 5 10(k) #K951725). Description of Device Modificati… | 2005 |
| * | K002858 | Xia Spine SystemSummary page 1…he existing Stryker Spine MANTIS Spinal System (Cleared through 5 10(k) #K061813), Stryker Spine Xia® Titanium Spinal System (cleared through 5 10(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Osteonics Spinal System (cleared through 5 10(k) #K951725). Description of Device Modification This S… | 2000 |
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 1…ng Stryker Spine MANTIS Spinal System (Cleared through 5 10(k) #K061813), Stryker Spine Xia® Titanium Spinal System (cleared through 5 10(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Osteonics Spinal System (cleared through 5 10(k) #K951725). Description of Device Modification This Special 51… | 2006 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…yker Spine Xia® Titanium Spinal System (cleared through 5 10(k) #K013823, #K043473, K002858, K060361) and Stryker Spine Osteonics Spinal System (cleared through 5 10(k) #K951725). Description of Device Modification This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spina… | 1995 |
What descends from it? (111)
See all 1112 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 12 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K092631 (Stryker Spine, 2009) has gone furthest, with 110 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. 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 MANTIS® 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073151: Mantis 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/K073151
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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