# K973425: The Mehdian Lumbo-Sacral Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Feb 27, 1998 after 170 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K991678: Whiteside Biomechanics Spinal System (1999), 0 descendants of its own

## Indications for use
1. The device system consisting screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses: (a) anterolateral screw fixation to the non-cervical spine, (b) anterior screw fixation to the cervical spine The anterolateral/anterior system is intended for use in the following indications: (1) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. (b) Spondylolisthesis (c) Trauma (d) Spinal Stenosis (e) Scoliosis (f) Kyphosis (g) Tumor (h) Pseudoarthrosis (i) Revision of previous surgery (j) Neoplastia 2. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use: (a) hook and sacral/iliac screw fixation to the non-cervical spine The non-pedicle posterior devices may be used for the following indications: (a) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. (b) Spondylolisthesis (c) Trauma (d) Spinal Stenosis (e) Scoliosis (f) Kyphosis (g) Tumor (h) Pseudoarthrosis (i) Revision of previous surgery (j) Neoplastia 3. The device system consisting of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients: (a) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint (b) Who are receiving fusions using autogenous bone graft only (c) Who are having the device fixed or attached to the lumbar and sacral spine (d) Who are having the device removed after the development of a solid fusion mass The levels of pedicle screws fixation will be L3-S1.

Source page: https://510kreport.com/device/K973425
Methodology: https://510kreport.com/methodology