510(k) · Cleared
ClearedDevine Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Orthmed Medical Instrument Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Nov 22, 2011 as substantially equivalent to K082617 (Trauson (Jiangsu) Medical Instrument Co., Ltd., 2009) after a 159-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 22, 2011
- Review
- 159 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951725 (1995). 8 ancestors in all, the oldest K950697 (1995). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK111690 Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK161151 Spinal fixation systemCanwell Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK172826 Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK172267 IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016 · cites it directly1descendant
- K172826Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2018 · 2 generations on0descendants
- K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2018 · cites it directly0descendants
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) | K111690 | Devine Spinal System | Changzhou Orthmed Medical Instrument Co., Ltd. | 2011 | — |
| +1 | K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016 | — |
| +2 | K172826 | Cellent Spinal Systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | 2018 | — |
| +1 | K172267 | IRENE Thoracolumbar Fixation System | Tianjin Zhengtian Medical Instrument Co., Ltd. | 2018 | — |
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 |
|---|---|---|
| 2016 | 1 | 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 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? (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 2…us fusion (5) pseudarthrosis, (6) spinal stenosis. itis not intcnidcd Ibr pedJicle screw fixation above 18. 5. Predicate Device Identification 510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Manufacturer: TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. 6. Device… | 2009 |
What descends from it? (3)
2 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 16 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K161151 (Canwell Medical Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 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. 2011, 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?
Devine 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.e., fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above 18.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111690: Devine Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111690
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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