# K962628: Moss Miami Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Mar 18, 1997 after 256 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.
905 later devices descend from it; 9 cite it directly.
1 of 906 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 Spinal System: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Spinal Sytem, Pedicle Fixation: named in the summary without a submission number
- (no number) DePuy Motech MOSS Spinal System, Pedicle Fixation: named in the summary without a submission number

## Most influential descendants
- K053115: Xia Spinal System (2005), 889 descendants of its own
- K050461: Xia 4.5 Spinal System (2005), 742 descendants of its own
- K052761: Modification to:  Xia 4.5 Spinal System (2005), 735 descendants of its own
- K060361: Xia Spinal System, Xia 4.5 Spinal System (2006), 734 descendants of its own
- K060979: Xia Titanium and 4.5 Spinal Systems (2006), 710 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 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/K962628
Methodology: https://510kreport.com/methodology