510(k) · Cleared
ClearedMedinaut Kyphoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imedicom · NDN Cement, Bone, Vertebroplasty
Cleared on Apr 4, 2014 as substantially equivalent to K041454 (Kyphon, Inc., 2004) and 2 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1998. 7 later devices descend from it.
- Decided
- Apr 4, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K981251 (1998). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 2 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 1 generation backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- This deviceK133669 Medinaut Kyphoplasty SystemImedicom · 2014
- Descendant · cites it directly · 4 of its ownK153296 MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK202027 Balex bone Expander SystemTaeyeon Medical Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK192335 TRACKER Kyphoplasty SystemGS Medical Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK232842 Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK221142 Kyphoplasty Balloon SystemOK Medinet Korea Co., Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. · 2016 · cites it directly4descendants
- K202027Balex bone Expander SystemTaeyeon Medical Co., Ltd. · 2021 · cites it directly1descendant
- K192335TRACKER Kyphoplasty SystemGS Medical Co., Ltd. · 2019 · cites it directly1descendant
- K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
- K221142Kyphoplasty Balloon SystemOK Medinet Korea Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −2 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −1 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| 0 (this device) | K133669 | Medinaut Kyphoplasty System | Imedicom | 2014 | — |
| +1 | K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | 2016 | — |
| +1 | K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | 2021 | — |
| +1 | K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | 2019 | — |
| +2 | K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | 2024 | — |
| +2 | K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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? (3)
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…UT Kyphoplasty System Common Name -Inflatable Bone Tamp Classification Name - Arthroscope Predicate Device: KyphX Inflatable Bone Tamp, KO010246 & K041454 Kyphon Inflatable Bone Tamp, K98 125 1 5. Proposed Device Classifications & Citations: Classification: Class 11… | 2004 |
| * | K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3…Summary page 2…0. 1100 Review Panel: Orthopedic 6. Predicate Device Identification: 5 10(k) Number: Primary Predicate: K04 1454 Secondary Predicates: K010246 and K981251 Product Name: KyphX® Inflatable Bone Tamp Manufacturer's Name: Kyphon Inc. (Medtronic) 7. Device Des… | 2001 |
| * | K981251 | Kyphon Inflatable Bone TampSummary page 1…latable Bone Tamp Classification Name - Arthroscope Predicate Device: KyphX Inflatable Bone Tamp, KO010246 & K041454 Kyphon Inflatable Bone Tamp, K98 125 1 5. Proposed Device Classifications & Citations: Classification: Class 11 Product Code A: NDN Regulation Numb… | 1998 |
What descends from it? (7)
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 16 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K153296 (Imedicom Co., Ltd., 2016) has gone furthest, with 4 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. 2014, 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 and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This 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/K133669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133669: Medinaut Kyphoplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133669
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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