510(k) · Cleared
ClearedTRACKER Plus Kyphoplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GS Medical Co., Ltd. · NDN Cement, Bone, Vertebroplasty
Cleared on Oct 28, 2021 as substantially equivalent to K192335 (GS Medical Co., Ltd., 2019) and 1 other predicate after a 140-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Oct 28, 2021
- Review
- 140 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981251 (1998). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 5 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 4 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- 3 generations backK132620 Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv…Pan Medical, Ltd. · 2014
- 2 generations backK150322 InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV…Pan Medical, Ltd. · 2015
- 1 generation backK162453 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty…Pan Medical, Ltd. · 2016
- This deviceK211797 TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −5 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −4 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| −3 | K132620 | Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty… | Pan Medical, Ltd. | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K192335 | TRACKER Kyphoplasty SystemSummary page 5…Code Number TRACKER Primary 21 CFR NDN, HRX GS Medical Co. K192335 Kyphoplasty 888.3027 Ltd. System 11G InterV Secondary 21 CFR NDN… | 2019 |
| * | K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Summary page 5…. K192335 Kyphoplasty 888.3027 Ltd. System 11G InterV Secondary 21 CFR NDN, HRX Pan Medical Ltd. K162453 Kyphoplasty 888.3027 Catheter (Flex) IV. DEVICE DESCRIPTION The TRACKER Plus Kyphoplasty System is inten… | 2016 |
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 23 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 10 ancestors have 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. 2021, 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 TRACKER Plus 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211797: TRACKER Plus 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/K211797
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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