# K964024: Depuy Motech Titanium Moss Miami Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Mar 26, 1997 after 170 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K955348 (1996). 1 ancestor in all.
700 later devices descend from it; 14 cite it directly.
1 of 702 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- (no number) DePuy Motech MOSS Miami Spinal System - Anterior Use: named in the summary without a submission number

## Most influential descendants
- K992168: Moss Miami 6.35MM Polyaxial Screw (1999), 547 descendants of its own
- K982511: Depuy Motech Moss Miami Spinal Systems (1998), 413 descendants of its own
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), 410 descendants of its own
- K073126: Expedium Spine System (2007), 304 descendants of its own
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) (2002), 294 descendants of its own

## Indications for use
The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, non-pedicle screw fixation 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 back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K964024
Methodology: https://510kreport.com/methodology