# K030383: Modification to Moss Miami Spinal System Polyaxial Screws

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Feb 26, 2003 after 21 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: 3 generations back to K951116 (1995). 15 ancestors in all.
410 later devices descend from it; 23 cite it directly.
0 of 426 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953915: Moss Miami Spinal System (Anterior Use), Depuy, Inc. (1996) Summary page 1.
- K982320: Depuy Motech Moss Miami Spinal System, Depuy, Inc. (1998) Summary page 1.
- K982511: Depuy Motech Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K982011: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998) Summary page 1.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001)

## Most influential descendants
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System (2007), 180 descendants of its own
- K093077: Zodiac Polyaxial Spinal Fixation System (2009), 170 descendants of its own
- K100685: Zodiac Polyaxial Spinal Fixation System (2010), 168 descendants of its own
- K133221: Arsenal Spinal Fixation System (2014), 150 descendants of its own
- K120291: OP Spine System (2012), 138 descendants of its own

## Indications for use
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies). When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 - S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K030383
Methodology: https://510kreport.com/methodology