510(k) · Cleared
ClearedOsseoflex SB Inflatable Bone Tamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseon Therapeutics, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Oct 23, 2012 as substantially equivalent to K041454 (Kyphon, Inc., 2004) and 6 other predicates after a 64-day review. Its family tree reaches back 5 generations to 1998. 8 later devices descend from it.
- Decided
- Oct 23, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K981251 (1998). 9 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 4 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 3 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 2 generations backK090211 Inflatable Bone TampCardinal Health, Inc. · 2009
- 1 generation backK093463 Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 2010
- This deviceK122533 Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK140937 Osseoflex SBOsseon, LLC · 2014
- Descendant · cites it directly · 6 of its ownK141930 Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK150607 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight…Osseon, LLC · 2015
- Descendant · 3 generations on · 3 of its ownK192449 Joline Kyphoplasty System AllevoJoline GmbH & Co. KG · 2020
- Descendant · 4 generations on · 2 of its ownK223709 Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K140937Osseoflex SBOsseon, LLC · 2014 · cites it directly7descendants
- K141930Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC · 2014 · cites it directly6descendants
- K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlOsseon, LLC · 2015 · 2 generations on4descendants
- K192449Joline Kyphoplasty System AllevoJoline GmbH & Co. KG · 2020 · 3 generations on3descendants
- K223709Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −4 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −3 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −2 | K090211 | Inflatable Bone Tamp | Cardinal Health, Inc. | 2009 | — |
| −1 | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 | Care Fusion | 2010 | — |
| 0 (this device) | K122533 | Osseoflex SB Inflatable Bone Tamp | Osseon Therapeutics, Inc. | 2012 | — |
| +1 | K140937 | Osseoflex SB | Osseon, LLC | 2014 | — |
| +1 | K141930 | Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML | Osseon, LLC | 2014 | — |
| +2 | K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | 2015 | — |
| +3 | K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020 | — |
| +4 | K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…HRX Class 11per 21CFR §888.3027. Procode NDN Product Code(s)OF05 Legally marketed device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I clai… | 2004 |
| * | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17ASummary page 1…Class 11per 21CFR §888.3027. Procode NDN Product Code(s)OF05 Legally marketed device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I claimed Reas… | 2003 |
| * | K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3…Summary page 1…Class 11per 21CFR §888.3027. Procode NDN Product Code(s)OF05 Legally marketed device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I claimed Reason for 5… | 2001 |
| * | K981251 | Kyphon Inflatable Bone TampSummary page 1…Class 11per 21CFR §888.3027. Procode NDN Product Code(s)OF05 Legally marketed device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I claimed Reason for 5 10(k)… | 1998 |
| * | K103064 | Avamax Vertebral BalloonSummary page 1…Legally marketed device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I claimed Reason for 5 10(k) New Device Device Description The Osseoflexo SB… | 2011 |
| * | K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Summary page 1…marketed device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I claimed Reason for 5 10(k) New Device Device Description The Osseoflexo SB is desig… | 2010 |
| * | K090211 | Inflatable Bone TampSummary page 1…device(s) Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 to which equivalence is CareFusion Inflatable Bone Tamp, K 103064, K093463, K090211I claimed Reason for 5 10(k) New Device Device Description The Osseoflexo SB is designed for u… | 2009 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K140937 (Osseon, LLC, 2014) has gone furthest, with 7 descendants of its own.
- 22 other devices also cite its predicate K041454.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethyltmethaciylate (PMA4A) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122533: Osseoflex SB Inflatable Bone Tamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122533
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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