510(k) · Cleared
ClearedKMC Kyphoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Kinetic Medical Co., Ltd. · NDN Cement, Bone, Vertebroplasty
Cleared on Sep 17, 2012 as substantially equivalent to K103231 (Medtronic Spine, LLC, 2011) after a 272-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Sep 17, 2012
- Review
- 272 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K953522 (1996). 6 ancestors in all, the oldest K955869 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 4 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 3 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- 2 generations backK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- 1 generation backK103231 Kyphon Inflation SyringeMedtronic Spine, LLC · 2011
- This deviceK113742 KMC Kyphoplasty SystemShanghai Kinetic Medical Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −4 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −3 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| −2 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| −1 | K103231 | Kyphon Inflation Syringe | Medtronic Spine, LLC | 2011 | — |
| 0 (this device) | K113742 | KMC Kyphoplasty System | Shanghai Kinetic Medical Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K061222 | FDA’s K061222 is Injectra Injection Needle Our reading of the summary gave K061222, FDA’s number for Injectra Injection Needle (Medi-Globe Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Kyphx Inflatable Bone Tamp”. Kept off the family tree. Summary page 1…sed with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. Predicate Devices K061222 Kyphx Inflatable Bone Tamp Kyphon Inc. K103231 Kyphon Inflation Syringe Kyphon Inc === P… | 2006 |
| * | K103231 | Kyphon Inflation SyringeSummary page 1…indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. Predicate Devices K061222 Kyphx Inflatable Bone Tamp Kyphon Inc. K103231 Kyphon Inflation Syringe Kyphon Inc… | 2011 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 KMC 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. 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/K113742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113742: KMC 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/K113742
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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