# K982494: BWM Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Sep 8, 1998 after 53 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
No predicates in its family tree.
206 later devices descend from it; 2 cite it directly.
0 of 207 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 its predicate without a number.
- (no number) Synthes® Spine’s Universal Spinal System (USS): named in the summary without a submission number
- (no number) Isola® Spinal System by Acromed®: named in the summary without a submission number
- (no number) DePuy Motech MOSS Miami Spinal System: named in the summary without a submission number

## Most influential descendants
- K013688: Modification to Xia Spinal System (2001), 205 descendants of its own
- K052181: Modification to Xia Spinal System (2005), 202 descendants of its own
- K070631: Device Modification to Radius Spinal System (2007), 201 descendants of its own
- K082608: Radius Spinal System, Vitallium Rod #486613601 (2008), 200 descendants of its own
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod (2009), 169 descendants of its own

## Indications for use
The BWM Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral 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. Pedicle screw fixation is limited to L3 to S1 or the ilium. When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the system is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K982494
Methodology: https://510kreport.com/methodology