# K023804: Moss Miami Spinal System Pin Nut

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Jan 23, 2003 after 70 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: 1 generation back to K010742 (2001). 1 ancestor in all.
265 later devices descend from it; 3 cite it directly.
1 of 267 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010742: Moss Miami 5.5MM Titanium Pin Nut, Depuyacromed (2001)

## Most influential descendants
- K092473: Expedium Spine System (2009), 263 descendants of its own
- K101070: Expedium Spine System (2010), 260 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own
- K124058: Creo Stabilization System (2013), 172 descendants of its own
- K143633: CREO Stabilization System (2015), 158 descendants of its own

## Indications for use
When used as a posterior, noncervical hook, and/or sacral/iliac 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, 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 as a pedicle screw fixation system of the noncervical spine in skeletally mature 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 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 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

Source page: https://510kreport.com/device/K023804
Methodology: https://510kreport.com/methodology