510(k) · Cleared
ClearedIRENE Thoracolumbar Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Zhengtian Medical Instrument Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 6, 2018 as substantially equivalent to K111690 (Changzhou Orthmed Medical Instrument Co., Ltd., 2011) after a 222-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Mar 6, 2018
- Review
- 222 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951725 (1995). 9 ancestors in all, the oldest K950697 (1995). No later device cites it as a predicate yet.
- 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 deviceK172267 IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. · 2018
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) | 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 |
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 |
|---|---|---|---|
| * | K111690 | Devine Spinal SystemSummary page 4…1 CFR 888.3070 Thoracolumbosacral Pedicle Screw System, Class II Product Code: NKB D. Predicate Device Trade Name: Devine Spinal System 510(k) Number: K111690 Classification Regulation: 21 CFR 888.3070 Product Code: MNH. MNI Manufacturer: Changzhou Orthmed Medical Instrume… | 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 23 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.
- 1 other device also cites its predicate K111690.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
IRENE Thoracolumbar Fixation System 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, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172267: IRENE Thoracolumbar 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/K172267
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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