# K102235: Mantis Spinal System & Mantis Redux Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Aug 24, 2010 after 15 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: 7 generations back to K950697 (1995). 44 ancestors in all.
109 later devices descend from it; 5 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092631: Mantis Redux Spinal System, Stryker Spine (2009)
- K063428: Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 1.
- K002858: Xia Spine System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K043473: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 1.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 1.

## Most influential descendants
- K103292: Trio Trauma Spinal System (2011), 85 descendants of its own
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal (2013), 84 descendants of its own
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K111478: Stryker Spine Power Adaptor (Accessory Instrument) (2011), 34 descendants of its own
- K120434: Power Adaptor Instrument Accessory (2012), 32 descendants of its own

## Indications for use
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-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 (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 the MANTIS® Spinal System and MANTIS® Redux Spinal System.

Source page: https://510kreport.com/device/K102235
Methodology: https://510kreport.com/methodology