# K980447: Depuy Motech Moss Miami Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 14, 1998 after 68 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
No predicates in its family tree.
381 later devices descend from it; 8 cite it directly.
0 of 382 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 its predicate without a number.
- (no number) DePuy Motech MOSS Miami Spinal System: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Spinal System, Pedicle Fixation: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Spinal System, Anterior Use: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Spinal System, 4mm rod: named in the summary without a submission number
- (no number) Sofamor Danek TSRH Spinal System: named in the summary without a submission number

## Most influential descendants
- K020674: Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw (2002), 305 descendants of its own
- K013558: Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw (2002), 304 descendants of its own
- K022605: Blackstone Spinal Fixation System Staple & Washer (2002), 302 descendants of its own
- K023498: Modification to Blackstone Spinal Fixation System (2002), 300 descendants of its own
- K022399: Blackstone Spinal Fixation System Spacer (2002), 300 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 patient 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 fixation 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/K980447
Methodology: https://510kreport.com/methodology