510(k) · Cleared
ClearedMEDINAUT Kyphoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imedicom Co., Ltd. · NDN Cement, Bone, Vertebroplasty
Cleared on Jul 29, 2016 as substantially equivalent to K133669 (Imedicom, 2014) after a 259-day review. Its family tree reaches back 4 generations to 1998. 4 later devices descend from it.
- Decided
- Jul 29, 2016
- Review
- 259 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981251 (1998). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 3 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 2 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 1 generation backK133669 Medinaut Kyphoplasty SystemImedicom · 2014
- This deviceK153296 MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK192335 TRACKER Kyphoplasty SystemGS Medical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK232842 Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK211797 TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK172871 SpineKure Kyphoplasty SystemHanchang Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K192335TRACKER Kyphoplasty SystemGS Medical Co., Ltd. · 2019 · cites it directly1descendant
- K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024 · cites it directly0descendants
- K211797TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd. · 2021 · 2 generations on0descendants
- K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −3 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −2 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −1 | K133669 | Medinaut Kyphoplasty System | Imedicom | 2014 | — |
| 0 (this device) | K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | 2016 | — |
| +1 | K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | 2019 | — |
| +1 | K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | 2024 | — |
| +2 | K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021 | — |
| +1 | K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K133669 | Medinaut Kyphoplasty SystemSummary page 4…▪ Classification regulation: Class II, 21 CFR 888.3027 / 21 CFR 888.1100 4. Predicate Device: ▪ MEDINAUT Kyphoplasty System by IMEDICOM Co., Ltd. (K133669) ▪ KyphX Inflatable Bone Tamp by Kyphon Inc. (K010246, K041454, K981251)… | 2014 |
| † | K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3… | 2001 |
| † | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | 2004 |
| † | K981251 | Kyphon Inflatable Bone Tamp | 1998 |
What descends from it? (4)
3 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 18 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K192335 (GS Medical Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K133669.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MEDINAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) 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/K153296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153296: MEDINAUT Kyphoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153296
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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