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SpineKure Kyphoplasty System

HAN CHANG CO., LTD · Model Balloon Catheter (SBC-10) · UDI-DI 08809300542928

NDN HRX

510(k) clearances

4,809

Adverse events (94 deaths)

Recalls

114

Facilities

Description

The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter’s main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).

Recalls

Date	Firm	Reason
2022-12-15	TEKNIMED SAS	Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
2021-05-18	Stryker Spine	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-05-18	Stryker Spine	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.