510(k) · Cleared
ClearedDouble Medical Universal Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Double Medical Technology, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 22, 2016 as substantially equivalent to K082617 (Trauson (Jiangsu) Medical Instrument Co., Ltd., 2009) after a 448-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 22, 2016
- Review
- 448 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951725 (1995). 8 ancestors in all, the oldest K950697 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- 3 generations backK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · Recalled
- 2 generations backK063601 Pilot Spinal SystemLife Spine · 2007
- 1 generation backK082617 Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2009
- This deviceK151458 Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| −3 | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | 2 |
| −2 | K063601 | Pilot Spinal System | Life Spine | 2007 | — |
| −1 | K082617 | Trauson General Spinal System (GSS) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009 | — |
| 0 (this device) | K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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 MNI? 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? (1)
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 |
|---|---|---|---|
| * | K082617 | Trauson General Spinal System (GSS)Summary page 4…ssification: II Classification Panel: Orthopedic Panel Product Code: MNI, MNH Regulation Number: 21 CFR Part 888.3070 3.4 Predicate Devices Information K082617 Trauson General Spinal System (GSS)… | 2009 |
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 5 other devices also cite its predicate K082617.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 – S1.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151458: Double Medical Universal 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/K151458
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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