# K983583: Depuy Acromed Moss and Moss Miami Spinal Systems

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Dec 3, 1998 after 51 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
No predicates in its family tree.
965 later devices descend from it; 26 cite it directly.
1 of 966 devices in its family (counting itself) has 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 (for posterior use): 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 indications: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami 4.0 mm Rod Spinal Subsystem: named in the summary without a submission number
- (no number) DePuy Motech Universal Spinal System and Transverse Rod Stabilizer: named in the summary without a submission number
- (no number) Biedermann Motech MOSS Miami Spinal System, 6.0mm Rod Subsystem: named in the summary without a submission number
- (no number) DePuy Motech Titanium MOSS Miami Spinal System: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Spinal System Ratchet Rods: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Titanium Sacral Extenders: named in the summary without a submission number

## Most influential descendants
- K010576: Monarch Spine System (2001), 596 descendants of its own
- K024348: Monarch Spine System (2003), 578 descendants of its own
- K992168: Moss Miami 6.35MM Polyaxial Screw (1999), 547 descendants of its own
- K021148: Monarch Spine System Commercially Pure Titanium Spinal Rod (2002), 496 descendants of its own
- K052131: Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods (2005), 495 descendants of its own

## Indications for use
When used as a posterior, noncervical 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, spondylol:sthesis, 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 matrue 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 pazients with severe spondylolisthesis (Grades 3 and 4) at the L.5-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/K983583
Methodology: https://510kreport.com/methodology