510(k) · Cleared
ClearedAesuclap Socon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 25, 1997 after a 152-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 25, 1997
- Review
- 152 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970285 Aesuclap Socon Spinal SystemAesculap, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK993551 Socon Spinal SystemAesculap, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993551Socon Spinal SystemAesculap, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970285 | Aesuclap Socon Spinal System | Aesculap, Inc. | 1997 | — |
| +1 | K993551 | Socon Spinal System | Aesculap, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (6)
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 |
|---|---|---|---|
| * | — | Spine System® by Aesculap JBS Named without a submission number | |
| * | — | TSRH Spinal Screws & System by Sofamor Danek Named without a submission number | |
| * | — | Selby System by Advanced Spine Fixation System Inc. Named without a submission number | |
| * | — | VSP® Spinal Fixation System by AcroMed Corp. Named without a submission number | |
| * | — | SYNERGY™ Posterior Spinal System by Cross Medical Products Inc. Named without a submission number | |
| * | — | Varifix System by Advanced Spine Fixation System Inc. Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993551 | Socon Spinal System | 2000 | 0 |
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?
- Of its descendants, K993551 (Aesculap, Inc., 2000) has gone furthest, with 0 descendants of its own.
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?
The Aesculap SOCON® Spinal System presented in this submission is intended only for patients with severe spondylolisthesis grades 3 and 4, at the L5-S1 vertebral joint, utilizing autologous bone graft, who are having the device fixed or attached to the lumbar and sacral spine and who are having the implants removed after the development of a solid fusion mass. Levels of pedicle screw fixation for this indication are from L3 to S1.
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/K970285 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970285: Aesuclap Socon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970285
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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