Kyphon Xpede Bone Cement
FDA 510(k) clearance K163032 · decided 2017-02-27
Clearance details
- K-number
- K163032
- Device name
- Kyphon Xpede Bone Cement
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-31
- Decision date
- 2017-02-27
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XeliteMed SuperM-Fix Spinal Bone Cement (K251896) | Xelite Biomed , Ltd. | 2026-01-28 |
| VCFix Spinal System (K250637) | Amber Implants | 2025-05-30 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (K243537) | Xelite Biomed , Ltd. | 2025-04-11 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775) | Xelite Biomed , Ltd. | 2024-09-18 |
| Balloon Inflation System (K232842) | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 |
| V-STRUT® Vertebral Implant (K240084) | Hyprevention | 2024-02-09 |
| Renova Spine Balloon Catheter (K231340) | Biopsybell S.R.L. | 2023-10-30 |
| INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697) | Slk Ortho, LLC | 2023-03-03 |
| SpineJack® Expansion Kit (K223294) | Stryker Instruments | 2022-12-20 |
| KYPHON VuE Bone Cement (K220131) | Tecres S.P.A. | 2022-04-18 |
| TRACKER Plus Kyphoplasty System (K211797) | GS Medical Co., Ltd. | 2021-10-28 |
| SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (K211238) | Stryker Instruments | 2021-06-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |