# K020426: MSD Wire System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Feb 26, 2002 after 18 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 K934007 (1994). 1 ancestor in all.
68 later devices descend from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934007: Sofamor Orfil Spine Fixation System, Sofamor Co. (1994) Summary page 1.

## Most influential descendants
- K072605: Malibu Spinal System (2007), 67 descendants of its own
- K122571: Malibu Spinal System with the Daytona Deformity System (2012), 62 descendants of its own
- K160902: Mariner Pedicle Screw System (2016), 60 descendants of its own
- K173882: SeaSpine Mariner Pedicle Screw System (2018), 56 descendants of its own
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own

## Indications for use
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. This system is intended for use only in the thoracic, lumbar and sacral levels of the spine. This system is not for use in the cervical spine. Specific indications include: 1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Pseudoarthrosis. Stenosis Spondylolisthesis. Spinal deformities such as scoliosis and lordosis. Fracture. Unsuccessful previous fusion surgery. Tumor resection.

Source page: https://510kreport.com/device/K020426
Methodology: https://510kreport.com/methodology