# K092631: Mantis Redux Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Sep 25, 2009 after 30 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: 6 generations back to K950697 (1995). 43 ancestors in all.
110 later devices descend from it; 3 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)
- K061813: Mantis Spinal System, Stryker Spine (2006). 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”.
- K073151: Mantis Spinal System, Stryker Corp. (2007) 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.
- K063428: Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 1.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 1.
- K062270: Radius Spinal System, Stryker Spine (2006) Summary page 1.
- K082608: Radius Spinal System, Vitallium Rod #486613601, Stryker Spine (2008) Summary page 1.

## Most influential descendants
- K102235: Mantis Spinal System & Mantis Redux Spinal System (2010), 109 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K092631
Methodology: https://510kreport.com/methodology