# K982511: Depuy Motech Moss Miami Spinal Systems

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Sep 14, 1998 after 56 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: 2 generations back to K951116 (1995). 9 ancestors in all.
413 later devices descend from it; 5 cite it directly.
0 of 423 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K953915: Moss Miami Spinal System (Anterior Use), Depuy, Inc. (1996) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.
- K951116: Acromed Pedicle Screw, Acromed Corp. (1995) Summary page 1.
- K951657: VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S), Spine Plate (S), Washer (S) & Nut (S), Acromed Corp. (1995) Summary page 1.
- K952236: Isola System, Acromed Corp. (1996) Summary page 1.
- K963639: Acromed Pedicle Screw, Acromed Corp. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K944736: VSP (Variable Screw Placement), Acromed Corp. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), 410 descendants of its own
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System (2007), 180 descendants of its own
- K093077: Zodiac Polyaxial Spinal Fixation System (2009), 170 descendants of its own
- K100685: Zodiac Polyaxial Spinal Fixation System (2010), 168 descendants of its own
- K133221: Arsenal Spinal Fixation System (2014), 150 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 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 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/K982511
Methodology: https://510kreport.com/methodology