510(k) · Cleared
ClearedTrauson General Spinal System (GSS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trauson (Jiangsu) Medical Instrument Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jan 15, 2009 as substantially equivalent to K063601 (Life Spine, 2007) after a 128-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.
- Decided
- Jan 15, 2009
- Review
- 128 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951725 (1995). 7 ancestors in all, the oldest K950697 (1995). 8 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- 2 generations backK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · Recalled
- 1 generation backK063601 Pilot Spinal SystemLife Spine · 2007
- This deviceK082617 Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK111690 Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK161151 Spinal fixation systemCanwell Medical Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK172826 Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK172267 IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK151458 Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd. · 2011 · cites it directly3descendants
- K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016 · 2 generations on1descendant
- K172826Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2018 · cites it directly0descendants
- K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2018 · 2 generations on0descendants
- K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| −2 | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | 2 |
| −1 | K063601 | Pilot Spinal System | Life Spine | 2007 | — |
| 0 (this device) | K082617 | Trauson General Spinal System (GSS) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009 | — |
| +1 | K111690 | Devine Spinal System | Changzhou Orthmed Medical Instrument Co., Ltd. | 2011 | — |
| +2 | K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016 | — |
| +1 | K172826 | Cellent Spinal Systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | 2018 | — |
| +2 | K172267 | IRENE Thoracolumbar Fixation System | Tianjin Zhengtian Medical Instrument Co., Ltd. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K063601 | Pilot Spinal SystemSummary page 2…ing Co., Ltd. Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, China, 200030 3. Predicate Device PILOT' Spinal System (K063601) Device Name: PILOT "m Spinal System Common Name: Pedicle screw spinal system Classification Name: 21 CFR… | 2007 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K111690 (Changzhou Orthmed Medical Instrument Co., Ltd., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K063601.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Trauson General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-\ql can be applied for anterior or anterolateral 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. When used as a posterior spine thoracic/lumbar system, Trauson General…
Read the full statement (115 words)
Trauson General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-\ql can be applied for anterior or anterolateral 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.
When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.
Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082617: Trauson General Spinal System (GSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082617
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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