# K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Dec 17, 2013 after 61 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K040583 (2004). 148 ancestors in all.
84 later devices descend from it; 4 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061813: Mantis Spinal System, Stryker Spine (2006) Summary page 3.
- K073151: Mantis Spinal System, Stryker Corp. (2007) Summary page 3.
- K092631: Mantis Redux Spinal System, Stryker Spine (2009) Summary page 3.
- K102235: Mantis Spinal System & Mantis Redux Spinal System, Stryker Spine (2010) Summary page 4.
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 3.
- K082608: Radius Spinal System, Vitallium Rod #486613601, Stryker Spine (2008) Summary page 3.
- K101144: Modification to:Radius Spinal System, Stryker Spine (2010)
- K052971: Stryker Spine Trio Spinal Fixation System, Stryker Spine (2005) Summary page 3.
- K062698: Trio + Spinal System, Stryker Spine (2006) Summary page 3.
- K070368: Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System, Stryker Corp. (2007) Summary page 3.
- K100737: Modification to: Trio+Spinal Fixation System, Stryker Spine (2010) Summary page 3.
- K103292: Trio Trauma Spinal System, Stryker Corporation (2011) Summary page 7.
- K982494: BWM Spine System, Howmedica Corp. (1998) Summary page 3.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 3.
- K031893: Xia Spinal System and Xia Stainless Steel System, Howmedica Osteonics Corp. (2003) Summary page 3.
- K043473: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 3.
- K052181: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 3.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 7.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 3.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 3.
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 3.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009)
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 3.
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 3.
- K060748: Modification to Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 3.
- K092605: Xia 4.5 Spinal System, Stryker Spine (2009) Summary page 3.
- K121342: Xia 4.5 Spinal System, Stryker Corp. (2012) Summary page 3.

## Cited in the summary but kept off the family tree
- K070630: Health Line International Corporation's Primary IV Solution Administration Set with Check Valve, Health Line International Corporation (Hlic) (2007). 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.

## Most influential descendants
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (2017), 15 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K133188
Methodology: https://510kreport.com/methodology