# K061813: Mantis Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Sep 19, 2006 after 84 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950697 (1995). 20 ancestors in all.
135 later devices descend from it; 5 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043473: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 1.
- K060361: Xia Spinal System, Xia 4.5 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.
- K951725: Osteonics Spinal System, Osteonics Corp. (1995) Summary page 1.
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 1.
- K001255: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K073151: Mantis Spinal System (2007), 111 descendants of its own
- K092631: Mantis Redux Spinal System (2009), 110 descendants of its own
- 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

## Recalls of this device
- Apr 30, 2009 · Not classified · Z-1612-2009: The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the
- Apr 30, 2009 · Not classified · Z-1611-2009: The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the

## Indications for use
The MANTISTM Spinal System is intended for percutaneous, 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.

Source page: https://510kreport.com/device/K061813
Methodology: https://510kreport.com/methodology