510(k) · Cleared
ClearedSpinal Inner Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Dingjian Medical Appliance Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 11, 2015 as substantially equivalent to K122994 (Weigao Orthopaedic Device Co., Ltd., 2013) after a 417-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it.
- Decided
- Dec 11, 2015
- Review
- 417 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K031655 (2003). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK031655 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2003 · Recalled
- 2 generations backK042790 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK122994 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2013
- This deviceK143013 Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK222031 Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222031Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031655 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2003 | 1 |
| −2 | K042790 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K122994 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| 0 (this device) | K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| +1 | K222031 | Spinal Inner Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K122994 | Intramedullary Nail SystemSummary page 6…Page 2 of 5 III. PREDICATE DEVICE Primary predicate: General Spinal System K122994; This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DE… | 2013 |
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 |
|---|---|---|---|
| K222031 | Spinal Inner Fixation System | 2022 | 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 12 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K222031 (Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122994.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 inner fixation 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; pseudoarthrosis; 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143013: Spinal Inner Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143013
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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