# K992168: Moss Miami 6.35MM Polyaxial Screw

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Sep 23, 1999 after 87 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955348 (1996). 4 ancestors in all.
547 later devices descend from it; 22 cite it directly.
0 of 552 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.
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 1.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K953882: Moss Miami Polyaxial Screw System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), 410 descendants of its own
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) (2002), 294 descendants of its own
- 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

## Indications for use
When used as a posterior, noncervical hook, and/or sacralfiliac 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 pedicie 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/K992168
Methodology: https://510kreport.com/methodology