510(k) · Cleared
ClearedSpinal fixation system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canwell Medical Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 21, 2016 as substantially equivalent to K111690 (Changzhou Orthmed Medical Instrument Co., Ltd., 2011) after a 149-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Sep 21, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951725 (1995). 9 ancestors in all, the oldest K950697 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- 4 generations backK052971 Stryker Spine Trio Spinal Fixation SystemStryker Spine · 2005 · Recalled
- 3 generations backK063601 Pilot Spinal SystemLife Spine · 2007
- 2 generations backK082617 Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2009
- 1 generation backK111690 Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd. · 2011
- This deviceK161151 Spinal fixation systemCanwell Medical Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK172826 Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172826Cellent Spinal SystemsJiangsu Trauhui 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 |
|---|---|---|---|---|---|
| −5 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| −4 | K052971 | Stryker Spine Trio Spinal Fixation System | Stryker Spine | 2005 | 2 |
| −3 | K063601 | Pilot Spinal System | Life Spine | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016 | — |
| +1 | K172826 | Cellent Spinal Systems | Jiangsu Trauhui 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 |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K111690 | Devine Spinal SystemSummary page 5…PREDICATE DEVICE K161151 - Page 2 of 5 Primary predicate: Devine Spinal System K111690; This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEV… | 2011 |
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 |
|---|---|---|---|
| K172826 | Cellent Spinal Systems | 2018 | 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?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K172826 (Jiangsu Trauhui Medical Instrument Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111690.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Spinal fixation 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 T8.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161151: Spinal fixation system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161151
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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