# K960451: Webb-Morley Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Buckman Co., Inc.
- Decided: Apr 18, 1996 after 79 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
Longest line of descent: 1 generation back to K932029 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932029: TSRH Spinal Screws, Sofamor Danek Mfg., Inc. (1995) Summary page 1.
- K945064: Selby Instrumentation, Advanced Spine Fixation Systems, Inc. (1995) Summary page 1.

## Indications for use
Reduction and stabilization of grades III & IV spondylolisthesis of the fifth lumbar to first sacral vertebral interspace only. The Webb-Morley Spine System is for temporary use and must be accompanied by the application of autogenous source bone graft only. Once solid fusion is achieved, surgical removal of the device system is recommended. Planned removal of the device occurs within one year of the original surgery in adults and within two years of reaching skeletal maturity for adolescents.

Source page: https://510kreport.com/device/K960451
Methodology: https://510kreport.com/methodology