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 Geasure Medical Apparatus and Instruments Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 28, 2022 as substantially equivalent to K143013 (Changzhou Dingjian Medical Appliance Co., Ltd., 2015) after a 109-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Oct 28, 2022
- Review
- 109 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031655 (2003). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK031655 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2003 · Recalled
- 3 generations backK042790 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK122994 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2013
- 1 generation backK143013 Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- This deviceK222031 Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031655 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2003 | 1 |
| −3 | K042790 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K122994 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| −1 | K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| 0 (this device) | 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 |
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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K143013 | Spinal Inner Fixation SystemSummary page 4…Co., Ltd. Trade name Spinal Inner Fixation System 510(K) Number K143013 Regulatory Class II Regulation Primary Predicate 21 CF… | 2015 |
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 6.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
Spinal Inner Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222031: Spinal Inner 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/K222031
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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