510(k) · Cleared
ClearedJoline Kyphoplasty System Allevo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joline GmbH & Co. KG · NDN Cement, Bone, Vertebroplasty
Cleared on May 27, 2020 as substantially equivalent to K150607 (Osseon, LLC, 2015) after a 264-day review. Its family tree reaches back 9 generations to 1998. 3 later devices descend from it.
- Decided
- May 27, 2020
- Review
- 264 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981251 (1998). 13 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 5 generations between
- 3 generations backK140937 Osseoflex SBOsseon, LLC · 2014
- 2 generations backK141930 Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014
- 1 generation backK150607 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight…Osseon, LLC · 2015
- This deviceK192449 Joline Kyphoplasty System AllevoJoline GmbH & Co. KG · 2020
- Descendant · cites it directly · 2 of its ownK223709 Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK260203 Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252458 Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 8 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 7 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 6 generations backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- 5 generations backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- 4 generations backK122533 Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012
- 3 generations backK140937 Osseoflex SBOsseon, LLC · 2014
- 2 generations backK141930 Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014
- 1 generation backK150607 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight…Osseon, LLC · 2015
- This deviceK192449 Joline Kyphoplasty System AllevoJoline GmbH & Co. KG · 2020
Most influential descendants
Showing 3 of 3 · See all- K223709Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. · 2023 · cites it directly2descendants
- K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
- K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −8 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −7 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −6 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| −5 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| −4 | K122533 | Osseoflex SB Inflatable Bone Tamp | Osseon Therapeutics, Inc. | 2012 | — |
| −3 | K140937 | Osseoflex SB | Osseon, LLC | 2014 | — |
| −2 | K141930 | Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML | Osseon, LLC | 2014 | — |
| −1 | K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | 2015 | — |
| 0 (this device) | K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020 | — |
| +1 | K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023 | — |
| +2 | K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 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 |
|---|---|---|---|
| * | K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlSummary page 4…ssification Panel: Orthopedic Regulation Number: 21 CFR sections 888.1100 and 888.3027 C1. PRIMARY PREDICATE DEVICE K150607 Osseoflex SB C2. REFERENCE DEVICE K140937 Osseoflex SB Apr… | 2015 |
| † | K140937 | Osseoflex SB | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223709 | Kyphoplasty Balloon Catheter | 2023 | 2 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K223709 (Jiangsu Changmei Medtech Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Joline® Kyphoplasty System Allevo is 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/K192449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192449: Joline Kyphoplasty System Allevo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192449
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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