# K991678: Whiteside Biomechanics Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: Aug 12, 1999 after 87 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K973425 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973425: The Mehdian Lumbo-Sacral Pedicle Screw System, Corin USA (1998) Summary page 1.

## Indications for use
1.) The device system consisting of pedicle 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: 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.) Previous failed fusion 2.) The device system consisting of hooks, screws, washers, spacer, when utilized as a non-pedicle posterior system is intended for use in the following: a.) Hook and sacral/iliac screw fixation to the non-cervical spine. The non-pedicle posterior system is intended for use in 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.) Previous failed fusion 3.) The device system 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: and d.) Who are having the device removed after the development of a solid fusion mass. The levels of pedicle screws fixation are limited to L3-S1. The devices are manufactured from Titanium Alloy: ASTM F138 or Stainless Steel: ASTM F1472-93. Only components manufactured from the same material may be used in combination.

Source page: https://510kreport.com/device/K991678
Methodology: https://510kreport.com/methodology