Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NDN — Predicate Candidate Screening
108 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
275 days90th percentile
108clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | 2026-01-28 | 222 | 0 |
| K250637 | VCFix Spinal System | Amber Implants | 2025-05-30 | 88 | 0 |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement Sys | Xelite Biomed , Ltd. | 2025-04-11 | 147 | 0 |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | 2024-09-18 | 90 | 0 |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 | 168 | 0 |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | 2024-02-09 | 29 | 0 |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | 2023-10-30 | 174 | 0 |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | 2023-03-03 | 266 | 0 |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022-12-20 | 55 | 0 |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | 2022-04-18 | 90 | 0 |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021-10-28 | 140 | 0 |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, V | Stryker Instruments | 2021-06-25 | 60 | 0 |
| K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020-10-20 | 60 | 0 |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020-08-31 | 60 | 0 |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020-05-27 | 264 | 0 |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020-03-05 | 253 | 0 |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | 2019-12-04 | 98 | 0 |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. | 2019-11-08 | 66 | 0 |
| K181262 | SpineJack Expansion Kit | Vexim SA | 2018-08-30 | 111 | 0 |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | 2018-05-29 | 250 | 0 |
| K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | 2018-05-18 | 63 | 0 |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon C | G-21 S.R.L. | 2017-08-23 | 30 | 0 |
| K161114 | HIGH V+ | Teknimed Sas | 2017-04-12 | 357 | 1 |
| K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | 2017-02-27 | 119 | 0 |
| K162283 | DCM Kyphoplasty System | Dragon Crown Medical Co., Ltd. | 2017-02-06 | 175 | 0 |
| K162618 | CONCORD Plus Radiopaque Bone Cement | Globus Medical, Inc. | 2017-01-23 | 125 | 0 |
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kypho | Pan Medical , Ltd. | 2016-11-01 | 61 | 0 |
| K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | 2016-08-24 | 139 | 0 |
| K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | 2016-07-29 | 259 | 0 |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016-02-23 | 168 | 0 |
| K151227 | KYPHON XPEDE Bone Cement | Medtronic | 2015-11-16 | 193 | 0 |
| K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement | Stryker Corporation | 2015-06-12 | 95 | 1 |
| K150460 | KYPHON (R) HV-R(R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015-04-28 | 64 | 0 |
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straigh | Osseon, LLC | 2015-04-09 | 30 | 0 |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) | Pan Medical , Ltd. | 2015-03-06 | 25 | 0 |
| K143006 | GUARDIAN-SG Inflatable Bone Expander System | Bm Korea Co., Ltd. | 2015-01-16 | 88 | 0 |
| K141419 | ZVPLASTY | Zavation, LLC | 2014-09-12 | 106 | 0 |
| K141930 | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML | Osseon, LLC | 2014-08-21 | 36 | 0 |
| K141141 | KIVA VCF TREATMENT SYSTEM | Benvenue Medical, Inc. | 2014-08-14 | 104 | 0 |
| K140937 | OSSEOFLEX SB | Osseon, LLC | 2014-06-19 | 69 | 0 |
| K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV | Pan Medical , Ltd. | 2014-04-16 | 238 | 0 |
| K133669 | MEDINAUT KYPHOPLASTY SYSTEM | Imedicom | 2014-04-04 | 126 | 0 |
| K132817 | KIVA VCF TREATMENT SYSTEM | Benvenue Medical, Inc. | 2014-01-24 | 137 | 0 |
| K133372 | CROSSTREES PVA POD | Crosstrees Medical, Inc. | 2013-12-06 | 35 | 0 |
| K130089 | CROSSTREES PVA POD | Crosstrees Medical, Inc. | 2013-08-09 | 207 | 0 |
| K122503 | PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX | Neuro Therm, Inc. | 2013-06-25 | 313 | 0 |
| K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | Synthes (Usa), LLC | 2013-05-20 | 118 | 0 |
| K123942 | STRYKER IVAS BALLOON CATHETER | Stryker Corporation | 2013-04-03 | 104 | 0 |
| K130402 | SPIDER SYSTEM KOLIBRI CEMENT NEEDLE | Sintea Plustek, LLC | 2013-04-01 | 41 | 0 |
| K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | Tecres S.P.A. | 2013-03-28 | 248 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda