# K013296: Moss Miami Spinal Systems

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Oct 9, 2001 after 7 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 1 generation back to K983583 (1998). 3 ancestors in all.
184 later devices descend from it; 2 cite it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K001372: E-Z Link Cross Connector, Depuyacromed (2000) Summary page 1.
- K001470: E-Z Link Cross Connector, Depuyacromed (2000)

## Most influential descendants
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer (2010), 178 descendants of its own
- K102488: Apex Spine System W/ Cocr Rods (2010), 177 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own
- K113058: Tiger Spine System (2012), 81 descendants of its own

## Indications for use
The Moss Miami Spine 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Moss Miami Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graift having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Moss Miami Spine System is also a hook and sacralfiliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphasis), tumor, and previous failed fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K013296
Methodology: https://510kreport.com/methodology