510(k) · Cleared
ClearedWebb-Morley Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buckman Co., Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Apr 18, 1996 as substantially equivalent to K932029 (Sofamor Danek Mfg., Inc., 1995) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 18, 1996
- Review
- 79 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932029 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932029 TSRH Spinal ScrewsSofamor Danek Mfg., Inc. · 1995
- This deviceK960451 Webb-Morley Spine SystemBuckman Co., Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932029 | TSRH Spinal Screws | Sofamor Danek Mfg., Inc. | 1995 | — |
| 0 (this device) | K960451 | Webb-Morley Spine System | Buckman Co., Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932029 | TSRH Spinal ScrewsSummary page 1…Name(s): Spondylolisthesis Spinal Fixation Device System Classification Code(s): 87MNH Substantially Equivalent Device(s) 1. TSRH® Posterior Spine System Sofamor/Danek K932029 2. Posterior Lumbar Sacral Attachment (PLSA) Spine System Advanced Spine Fixation Systems K945064 david/ebi/webb3.doc === Page… | 1995 |
| * | K945064 | Selby InstrumentationSummary page 1…ly Equivalent Device(s) 1. TSRH® Posterior Spine System Sofamor/Danek K932029 2. Posterior Lumbar Sacral Attachment (PLSA) Spine System Advanced Spine Fixation Systems K945064 david/ebi/webb3.doc Device Description Background. This document summarizes safety and effectiveness informatio… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960451: Webb-Morley Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960451
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026