# K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Aug 27, 2002 after 20 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: 3 generations back to K955348 (1996). 6 ancestors in all.
294 later devices descend from it; 29 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K002607: Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral Extenders, Depuyacromed (2000) Summary page 1.

## Most influential descendants
- K120291: OP Spine System (2012), 138 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K101278: Inertia Pedicle Screw System (2010), 111 descendants of its own
- K132412: Inertia Mis Pedicle Screw System (2013), 107 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 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/K022623
Methodology: https://510kreport.com/methodology