510(k) · Cleared
ClearedKeYi Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Keyi Medical Device Technology Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 8, 2019 as substantially equivalent to K012871 (Interpore Cross Intl., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- May 8, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K040583 (2004). 46 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 4 generations backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK093058 TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2009
- 2 generations backK103049 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- 1 generation backK111942 TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK190567 KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −4 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K093058 | TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2009 | — |
| −2 | K103049 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −1 | K111942 | TSRH Spinal Systems | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| 0 (this device) | K190567 | KeYi Spinal Fixation System | Beijing Keyi Medical Device Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K012871 | Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…Summary page 5…outine control of a sterilization process for medical devices. 5. Identification of Predicate Device Primary Predicate Device 510(k) Number: K012871 Product Name: SYNERGY TI INTEGRAL OPEN SCREWS Manufacturer: INTERPORE CROSS INTL.… | 2001 |
| * | K111942 | TSRH Spinal SystemsSummary page 6…510(k) Summary Page 3 of 6 Additional Predicate Device 510(k) Number: K111942 Product Name: TSRH Manufacturer: Medtronic 6. Non-Clinical Test Conclusion Non clinical tests were c… | 2011 |
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 15 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 4 of the 46 ancestors have a recall of any class.
- 3 other devices also cite its predicate K012871.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190567: KeYi 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/K190567
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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