510(k) · Cleared
ClearedThe Mehdian Lumbo-Sacral Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Feb 27, 1998 after a 170-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Feb 27, 1998
- Review
- 170 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973425 The Mehdian Lumbo-Sacral Pedicle Screw SystemCorin USA · 1998
- Descendant · cites it directly · 0 of its ownK991678 Whiteside Biomechanics Spinal SystemWhiteside Biomechanics, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991678Whiteside Biomechanics Spinal SystemWhiteside Biomechanics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973425 | The Mehdian Lumbo-Sacral Pedicle Screw System | Corin USA | 1998 | — |
| +1 | K991678 | Whiteside Biomechanics Spinal System | Whiteside Biomechanics, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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?
The FDA summary names no predicate by 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 |
|---|---|---|---|
| K991678 | Whiteside Biomechanics Spinal System | 1999 | 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, K991678 (Whiteside Biomechanics, Inc., 1999) 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?
1. The device system consisting 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: (1) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with…
Read the full statement (268 words)
1. The device system consisting 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:
(1) 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) Revision of previous surgery
(j) Neoplastia
2. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use:
(a) hook and sacral/iliac screw fixation to the non-cervical spine
The non-pedicle posterior devices may be used for 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) Revision of previous surgery
(j) Neoplastia
3. The device system consisting 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
(d) Who are having the device removed after the development of a solid fusion mass
The levels of pedicle screws fixation will be L3-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/K973425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973425: The Mehdian Lumbo-Sacral Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973425
Report an extraction error
Are you the manufacturer?
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