# K032855: Stryker Spine Maps System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: Dec 10, 2003 after 89 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
113 later devices descend from it; 3 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K052971: Stryker Spine Trio Spinal Fixation System (2005), 112 descendants of its own
- K062698: Trio + Spinal System (2006), 88 descendants of its own
- K070368: Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System (2007), 87 descendants of its own
- K100737: Modification to: Trio+Spinal Fixation System (2010), 86 descendants of its own
- K103292: Trio Trauma Spinal System (2011), 85 descendants of its own

## Recalls of this device
- Jul 1, 2009 · Not classified · Z-1886-2009: The Trio 3.5MM Hex socket has been reported to break under high stresses.

## Indications for use
The Stryker Spine MAPS System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Stryker Spine MAPS System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass. The Stryker Spine MAPS System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts. The Stryker Spine MAPS System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.

Source page: https://510kreport.com/device/K032855
Methodology: https://510kreport.com/methodology