510(k) · Cleared
ClearedGeneral Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Dean Medical Instrument Co, Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 3, 2014 as substantially equivalent to K082617 (Trauson (Jiangsu) Medical Instrument Co., Ltd., 2009) and 1 other predicate after a 247-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 3, 2014
- Review
- 247 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951725 (1995). 11 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 deviceK134011 General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd. · 2014
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) | K134011 | General Spinal System | Changzhou Dean Medical Instrument Co, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K082617 | Trauson General Spinal System (GSS)Summary page 5…enosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft. Predicate Device Identification 510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Manufacturer: Trauson (Jiangsu) Medical Instrument Co., Ltd. 510(k) Number: K… | 2009 |
| * | K042790 | CD Horizon Spinal SystemSummary page 5…ce Identification 510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Manufacturer: Trauson (Jiangsu) Medical Instrument Co., Ltd. 510(k) Number: K042790 Product Name: CD HORIZON ® Spinal System Predicate Device Name: CD HORIZON LEGACY 5.5mm Spinal System Manufacturer: Medtronic S… | 2004 |
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 19 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 5 other devices also cite its predicate K082617.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.¢. fracture or dislocation), (2) curvatures (scoliosis, kyphosts, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.
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/K134011 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134011: General Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134011
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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