510(k) · Cleared
ClearedMantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal
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 Dec 17, 2013 as substantially equivalent to K061813 (Stryker Spine, 2006) and 26 other predicates after a 61-day review. Its family tree reaches back 11 generations to 2004. 84 later devices descend from it.
- Decided
- Dec 17, 2013
- Review
- 61 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 28
Its longest line of descent runs back 11 generations to K040583 (2004). 148 ancestors in all, the oldest K781443 (1978). 84 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations between
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- 1 generation backK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
- This deviceK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · cites it directly · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · cites it directly · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- Descendant · 2 generations on · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 3 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
Show all 11 generations
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 8 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 7 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 6 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 5 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- 1 generation backK121342 Xia 4.5 Spinal SystemStryker Corp. · 2012
- This deviceK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · cites it directly83descendants
- K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · cites it directly31descendants
- K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 2 generations on15descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 2 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −8 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −7 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −6 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −5 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −2 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
| −1 | K121342 | Xia 4.5 Spinal System | Stryker Corp. | 2012 | — |
| 0 (this device) | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +1 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| +2 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| +2 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +3 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
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 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 12 | 0 |
| 2001 | 12 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 17 | 0 |
| 2005 | 19 | 0 |
| 2006 | 13 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 15 | 0 |
| 2024 | 16 | 0 |
| 2025 | 10 | 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? (28)
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 |
|---|---|---|---|
| * | K061813 | Mantis Spinal SystemSummary page 3…* KWP, KWQ, MNH, MNI, NK13, OSH Predicate Devices I. MANTIS® & MANTIS® Spinal Systems * K061813, K073151, K09263 1,andKl102235 2. Radius® Spinal System *… | 2006 |
| * | K073151 | Mantis Spinal SystemSummary page 3…* KWP, KWQ, MNH, MNI, NK13, OSH Predicate Devices I. MANTIS® & MANTIS® Spinal Systems * K061813, K073151, K09263 1,andKl102235 2. Radius® Spinal System * K062270,… | 2007 |
| * | K092631 | Mantis Redux Spinal SystemSummary page 3…* KWP, KWQ, MNH, MNI, NK13, OSH Predicate Devices I. MANTIS® & MANTIS® Spinal Systems * K061813, K073151, K09263 1,andKl102235 2. Radius® Spinal System * K062270, K07063, K0… | 2009 |
| * | K102235 | Mantis Spinal System & Mantis Redux Spinal SystemSummary page 4…ed 510(k) Sterility Review Guidance K90-1, Guidancefor Jndustiy and FDA. Intended Use MANTIS® & MANTIS Redlux Spinal Systems (K102235) The MANTIS® Spinal System and MANIS® Redlux Spinal System is intended for perc… | 2010 |
| * | K062270 | Radius Spinal SystemSummary page 3…* K061813, K073151, K09263 1,andKl102235 2. Radius® Spinal System * K062270, K07063, K082608, and KI10I1144 3. TRIO® & TRIO + Spinal Fixation Systems… | 2006 |
| Kept off the family tree | K070630 | FDA’s K070630 is Health Line International Corporation's Primary IV Solution Administration Set… Our reading of the summary gave K070630, FDA’s number for Health Line International Corporation's Primary IV… (Health Line International Corporation (Hlic)). Its FDA name has none of the distinctive words the summary uses for the device it names, “Radius® Spinal System”. Kept off the family tree. | 2007 |
| * | K082608 | Radius Spinal System, Vitallium Rod #486613601Summary page 3…* K061813, K073151, K09263 1,andKl102235 2. Radius® Spinal System * K062270, K07063, K082608, and KI10I1144 3. TRIO® & TRIO + Spinal Fixation Systems *… | 2008 |
| * | K101144 | Modification to:Radius Spinal System | 2010 |
| * | K052971 | Stryker Spine Trio Spinal Fixation SystemSummary page 3…* K062270, K07063, K082608, and KI10I1144 3. TRIO® & TRIO + Spinal Fixation Systems * K052971, K062698, K070368, and K100737 4. TRIO® Trauma Spinal System… | 2005 |
| * | K062698 | Trio + Spinal SystemSummary page 3…* K062270, K07063, K082608, and KI10I1144 3. TRIO® & TRIO + Spinal Fixation Systems * K052971, K062698, K070368, and K100737 4. TRIO® Trauma Spinal System * Kl03… | 2006 |
| * | K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemSummary page 3…2270, K07063, K082608, and KI10I1144 3. TRIO® & TRIO + Spinal Fixation Systems * K052971, K062698, K070368, and K100737 4. TRIO® Trauma Spinal System * Kl03292… | 2007 |
| * | K100737 | Modification to: Trio+Spinal Fixation SystemSummary page 3…K082608, and KI10I1144 3. TRIO® & TRIO + Spinal Fixation Systems * K052971, K062698, K070368, and K100737 4. TRIO® Trauma Spinal System * Kl03292… | 2010 |
| * | K103292 | Trio Trauma Spinal SystemSummary page 7…Trauma, XIA®. XJI® 3, and XIA®li 4.5 the Multi-Axis Cross Connectors.' TRIO® TRAUMA (K 103292) 1 he Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical… | 2011 |
| * | K982494 | BWM Spine SystemSummary page 3…Trauma Spinal System * Kl03292 5. XIA® Spinal Systems *K982494, K01 3823, K03 1893, K043473, K052181, K06036l1, and K060979… | 1998 |
| * | K013823 | Xia Spinal SystemSummary page 3…pinal System * Kl03292 5. XIA® Spinal Systems *K982494, K01 3823, K03 1893, K043473, K052181, K06036l1, and K060979 6. XI… | 2001 |
| * | K031893 | Xia Spinal System and Xia Stainless Steel SystemSummary page 3…em * Kl03292 5. XIA® Spinal Systems *K982494, K01 3823, K03 1893, K043473, K052181, K06036l1, and K060979 6. XIA® 3 Spina… | 2003 |
| * | K043473 | Modification to Xia Spinal SystemSummary page 3…* Kl03292 5. XIA® Spinal Systems *K982494, K01 3823, K03 1893, K043473, K052181, K06036l1, and K060979 6. XIA® 3 Spinal System… | 2005 |
| * | K052181 | Modification to Xia Spinal SystemSummary page 3…* Kl03292 5. XIA® Spinal Systems *K982494, K01 3823, K03 1893, K043473, K052181, K06036l1, and K060979 6. XIA® 3 Spinal System… | 2005 |
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 7…* Tumor; * Pseudloarthorisis; * and Failed Pervious Fusion XIA®R Spinal Systems (K060361) Ehe XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and poster… | 2006 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 3…XIA® Spinal Systems *K982494, K01 3823, K03 1893, K043473, K052181, K06036l1, and K060979 6. XIA® 3 Spinal System *K071373, K083393, K09129l1, and… | 2006 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 3…52181, K06036l1, and K060979 6. XIA® 3 Spinal System *K071373, K083393, K09129l1, and Kl113666 7. XIA® 4.5 Spinal System… | 2007 |
| * | K083393 | Xia 3 Spinal SystemSummary page 3…K06036l1, and K060979 6. XIA® 3 Spinal System *K071373, K083393, K09129l1, and Kl113666 7. XIA® 4.5 Spinal System * K0504… | 2009 |
| * | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | 2009 |
| * | K113666 | Xia 3 Spinal SystemSummary page 3…K06036l1, and K060979 6. XIA® 3 Spinal System *K071373, K083393, K09129l1, and Kl113666 7. XIA® 4.5 Spinal System * K050461, K06036l, K060748, K0… | 2012 |
| * | K050461 | Xia 4.5 Spinal SystemSummary page 3…*K071373, K083393, K09129l1, and Kl113666 7. XIA® 4.5 Spinal System * K050461, K06036l, K060748, K060979, K092605, and K 121342 Description of Device The ST… | 2005 |
| * | K060748 | Modification to Xia 4.5 Spinal SystemSummary page 3…*K071373, K083393, K09129l1, and Kl113666 7. XIA® 4.5 Spinal System * K050461, K06036l, K060748, K060979, K092605, and K 121342 Description of Device The STRYKER Spine thorac… | 2006 |
| * | K092605 | Xia 4.5 Spinal SystemSummary page 3…, K083393, K09129l1, and Kl113666 7. XIA® 4.5 Spinal System * K050461, K06036l, K060748, K060979, K092605, and K 121342 Description of Device The STRYKER Spine thoraco-lumbar spinal Fi… | 2009 |
| * | K121342 | Xia 4.5 Spinal SystemSummary page 3…7. XIA® 4.5 Spinal System * K050461, K06036l, K060748, K060979, K092605, and K 121342 Description of Device The STRYKER Spine thoraco-lumbar spinal Fixation systems, subject Modifications of th… | 2012 |
What descends from it? (84)
See all 844 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 9 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 21 of the 148 ancestors have a recall of any class.
- Of its descendants, K142381 (Stryker Corp., 2014) has gone furthest, with 83 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. 2013, 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 MANISO Redlux Spinal System is intended Ibr percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletbally mature patients as an adjunct to fiusion 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); *…
Read the full statement (1,092 words)
The MANTIS Spinal System and MANISO Redlux Spinal System is intended Ibr percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletbally mature patients as an adjunct to fiusion 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 (iLe. fracture or dislocation);
* Spinal Stenosis;
* Curvatre (i.e. scoliosis, kyphosis, and/or lordosis);
* Tumor
* Pseudoarthorisis; and
* Failed Previous Fusion
The Radius@ Spinal System is intended for use inthe noncen'ical spine. When used as an anterior/anterolatemal and posterior, noncervical pedicle and non-pedicle fixation system, the Radius8) Spinal system is intended to provide additional support during fussion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformnities:
* 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;
* Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
* Tumor;
* Pseudoarthorisis;
* and Failed Pervious Fusion
The Radiutd Spinal System can also be linked to the XIAO Titanium Spinal System via the 05.5mm to 06.0mmn Radiust) rod-to-rod connector.
The Stryker Spine TRIOV! Spinal Fixation System is intended fir posterior, noncervicai pedicle and non-pedicle fixation of the spine. The Stryker Spine TRIO6!Spinal Fixation System is indicated for
* Degenerative Disc Disease (ODD) (defined as back pain of discogenic origin with degeneration of the disc conflrmed by history and radiographic studies);
* Spondylolisthesis;
* Trauma (i.e. fracture or dislocation);
* Spinal Stenosis;
* Curvature (i.e. scoliosis, kyphosis, andlor lordosis);
* Tumor
* Pseudoaithorisis;
* and Failed Pervious Fusion
The TRIO'2 Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine TRIO@ Plate System is intended for posterior, noncervical (TIO-SI) pediele and nonpedicle fixation of the spine 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;
*Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
*Tumor,
* Psaudoarthorisis;
* and Failed Pervious Fusion
The Stryker Spine TRIOSt Spinal System is intended for posterior, noncervical pedicle and nanpedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
0 Degenerative Disc Disease (DDD) (defined as back pai of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
* Spondylolisthesis;
* Tmauma (i.e. fracture or dislocation);
a Spinal Stenosis;.
* Curvature (i.e. scoliosis, kyphasis, and/or lordosis);
& Tumor
a Pseudoarthorisis;
* and Fai led Pervious Fusion
The TRIOS + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIAS Pme-bent Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine TR108 TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
* Degenerative Disc Disease (DDD) (dcfined as back pain of discogenic origin with degeneration of the disc confirned by history and radiographic studies);
* Spondylolisthesis;
* Trauma (i.e. fracture or dislocation);
* Spinal Stenosis;
* Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
* Tumor
* Pseudoarthorisis;
* and Failed Pervious Fusion
The XIA@ Spinal System and XIAO 4.5 Spinal System are 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 degenerration of the disc confinmed by history and radiographic studies);
* Spondylolisthesis;
* Trauma (i.e., fr-acture or dislocation);
* Spinal Stenosis;
* Curvatures (i.e., Scoliosis, Kyphosis, and/or Lordosis);
* Tumor
* Pseudoarthroisis and;
* Failed previous fusion.
The 6mm diameter rods from the DIAPASONO Spinal System and OPUSOD Spinal System are intended to be used with the other components of the XIAO Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of dhe XIAdD Titanium Spinal System.
The XIAC 3 Spinal System is intended for use in the noncerv icat spine. When used as an mnterior/antemolatemal and posterior, noncorvical pedicle and non-pedicle fixation system, the XIAC) 3 Spinal System is intended to provide additional support during fusion using autograft or allografi 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);
* Spondylollistliesis;
* Trauma (i.e. fracture or dislocation);
* Spinal Stenosis;
* Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
* Tumor,
* Pseudoarthorisis;
* and Failed Pervious Fusion
The 05.5 mm rods from the Stryker Spine RadiusO Spinal System and the 06.0mm Vitailliumn Rods from the XIAOD Spinal System are intended to be used with the other components of the XIAO) 3 Spinal System.
When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIAO Spinal System implants are indicated as an adjunct to futsion to treat adolescent idiopathic scoliosis.
The XIAC 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft
Pediatric pedicle screw fixation is limited to a posterior approach.
The XIAO) 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervicall 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 confinmed by history and radiographic studies);
* Spondylolisthesis;
* Trauima (i.e. fracture or dislocation);
* Spinal Stenosis;
* Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
* Tumor
* Pseudoarthorisis;
* and Failed Pervious Fusion
The Stryker Spine DIAPASONt Spinal System, OPUSO Spinal System and XIAO 4.5 Spinal System can be linked to the X!AO 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, the XIAO 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA@ 4.5 Spinal System for pediatric use in intended to be used with autografi and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133188
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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