# K965145: Depuy Motech Moss Miami Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Mar 13, 1997 after 80 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.
182 later devices descend from it; 2 cite it directly.
0 of 183 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) MOSS Miami 5.0mm smooth rod: named in the summary without a submission number

## Most influential descendants
- K062513: Apex Spine System (2006), 179 descendants of its own
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer (2010), 178 descendants of its own
- K102488: Apex Spine System W/ Cocr Rods (2010), 177 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own

## Indications for use
The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratchet rods, 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 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/K965145
Methodology: https://510kreport.com/methodology