510(k) · Cleared
ClearedGuardian Inflatable Bone Expander System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bm Korea Co., Ltd. · NDN Cement, Bone, Vertebroplasty
Cleared on Nov 18, 2011 as substantially equivalent to K981251 (Kyphon, Inc., 1998) and 1 other predicate after a 164-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 164 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. 2 later devices descend from it, 1 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 deviceK111593 Guardian Inflatable Bone Expander SystemBm Korea Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK143006 GUARDIAN-SG Inflatable Bone Expander SystemBm Korea Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK162283 DCM Kyphoplasty SystemDragon Crown Medical Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView 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) | K111593 | Guardian Inflatable Bone Expander System | Bm Korea Co., Ltd. | 2011 | — |
| +1 | K143006 | GUARDIAN-SG Inflatable Bone Expander System | Bm Korea Co., Ltd. | 2015 | — |
| +2 | K162283 | DCM Kyphoplasty System | Dragon Crown Medical Co., Ltd. | 2017 | — |
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 |
| 2017 | 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…Classification Name - Arthroscope Cement, Bone Vertebroplasty 3. Predicate Device: Kyphon Inflatable Bone Tamp, K981251 KyphX Xpander Inflatable Bone Tamps, K04 1454 4. Product Code & Regulation Number: HRX, 21C.F… | 1998 |
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…Cement, Bone Vertebroplasty 3. Predicate Device: Kyphon Inflatable Bone Tamp, K981251 KyphX Xpander Inflatable Bone Tamps, K04 1454 4. Product Code & Regulation Number: HRX, 21C.F.R. 880.1100 NON, 21C.F.R. 888.3027… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143006 | GUARDIAN-SG Inflatable Bone Expander System | 2015 | 1 |
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 13 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, K143006 (Bm Korea Co., Ltd., 2015) has gone furthest, with 1 descendant 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. 2011, 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 GUARDIAN Inflatable Bone Expander 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/K111593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111593: Guardian Inflatable Bone Expander System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111593
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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