FDA Device Intelligence
Home › BERKELEY ADVANCED BIOMATERIALS, LLC › K2M VENADO HA/TCP Cancellous Granules

K2M VENADO HA/TCP Cancellous Granules

BERKELEY ADVANCED BIOMATERIALS, LLC · Model 4815-T6020 · UDI-DI 00816125021604

MQV Prescription
1
510(k) clearances
2,073
Adverse events (45 deaths)
0
Recalls
225
Facilities

Description

VENADO Granules Bone Graft System is a sterile bone graft comprised of Bi-Ostetic (60% hydroxyapatite and 40% beta-tri-calcium phosphate) granules. These materials have been the topic of extensive clinical studies for a several decades. VENADO Granules are safe and have excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. VENADO Granules are a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. VENADO Granules are an osteoconductive bone substitute shaped as granules that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The VENADO Granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. VENADO Granules are biocompatible and resorbs in the body as bone ingrowth occurs.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.