510(k) · Cleared
ClearedInter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter (Balloon Lenght: 15 MM), Interv Kyphopl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pan Medical, Ltd. · NDN Cement, Bone, Vertebroplasty
Cleared on Apr 16, 2014 as substantially equivalent to K981251 (Kyphon, Inc., 1998) and 1 other predicate after a 238-day review. Its family tree reaches back 3 generations to 1998. 5 later devices descend from it.
- Decided
- Apr 16, 2014
- Review
- 238 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981251 (1998). 4 ancestors in all. 5 later devices descend from it, 2 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 deviceK132620 Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv…Pan Medical, Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK150322 InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV…Pan Medical, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK162453 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty…Pan Medical, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK231340 Renova Spine Balloon CatheterBiopsybell S.R.L. · 2023
- Descendant · 2 generations on · 0 of its ownK211797 TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK172871 SpineKure Kyphoplasty SystemHanchang Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K150322InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter…Pan Medical, Ltd. · 2015 · cites it directly4descendants
- K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical, Ltd. · 2016 · cites it directly1descendant
- K231340Renova Spine Balloon CatheterBiopsybell S.R.L. · 2023 · 2 generations on0descendants
- K211797TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd. · 2021 · 2 generations on0descendants
- K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd. · 2018 · 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) | K132620 | Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty… | Pan Medical, Ltd. | 2014 | — |
| +1 | K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV… | Pan Medical, Ltd. | 2015 | — |
| +1 | K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter… | Pan Medical, Ltd. | 2016 | — |
| +2 | K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | 2023 | — |
| +2 | K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981251 | Kyphon Inflatable Bone TampSummary page 1…21 CFR 888.3027 Classification Regulation: 21 CFR 888.1100 Product Code(s): NON Predicate Device: Kyphon Inflatable Bone Tamp, K981251 Kyphx® Xpander Inflatable Bone Tamps, K04 1454 Reason for 51 0(k) submission: New Device 5… | 1998 |
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…de(s): NON Predicate Device: Kyphon Inflatable Bone Tamp, K981251 Kyphx® Xpander Inflatable Bone Tamps, K04 1454 Reason for 51 0(k) submission: New Device 5 10(k) Summary… | 2004 |
What descends from it? (5)
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 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, K150322 (Pan Medical, Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 13 other devices also cite its predicate K981251.
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?
InterV Kyphoplasty Catheter is intended to be used for 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 polymethymethacrylate (PMMA) bone cements).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132620: Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter (Balloon Lenght: 15 MM), Interv Kyphopl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132620
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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