510(k) · Cleared
ClearedKyphoplasty Balloon Dilatation Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Lange Medtech Co., Ltd. · HRX Arthroscope
Cleared on Nov 3, 2025 as substantially equivalent to K223709 (Jiangsu Changmei Medtech Co., Ltd., 2023) after a 90-day review. Its family tree reaches back 11 generations to 1998.
- Decided
- Nov 3, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K981251 (1998). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 7 generations between
- 3 generations backK150607 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight…Osseon, LLC · 2015
- 2 generations backK192449 Joline Kyphoplasty System AllevoJoline GmbH & Co. KG · 2020
- 1 generation backK223709 Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. · 2023
- This deviceK252458 Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 10 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 9 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 8 generations backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- 7 generations backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- 6 generations backK122533 Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012
- 5 generations backK140937 Osseoflex SBOsseon, LLC · 2014
- 4 generations backK141930 Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014
- 3 generations backK150607 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight…Osseon, LLC · 2015
- 2 generations backK192449 Joline Kyphoplasty System AllevoJoline GmbH & Co. KG · 2020
- 1 generation backK223709 Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. · 2023
- This deviceK252458 Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −10 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −9 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −8 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| −7 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| −6 | K122533 | Osseoflex SB Inflatable Bone Tamp | Osseon Therapeutics, Inc. | 2012 | — |
| −5 | K140937 | Osseoflex SB | Osseon, LLC | 2014 | — |
| −4 | K141930 | Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML | Osseon, LLC | 2014 | — |
| −3 | K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | 2015 | — |
| −2 | K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020 | — |
| −1 | K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023 | — |
| 0 (this device) | K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K223709 | Kyphoplasty Balloon CatheterSummary page 7…pe HRX Class II, 21CFR 888.1100 Tamp HXG Class I, 21CFR 888.4540 Premarket Notification: K223709 Manufacturer: Jiangsu Changmei Medtech Co., Ltd. Comparison of technological characteristics with the predicate d… | 2023 |
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 27 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K223709.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
Kyphoplasty Balloon Dilatation Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).
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/K252458 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252458: Kyphoplasty Balloon Dilatation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252458
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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