Intrablock Bioball Hip System (IBS)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K123619 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K141377 Active Cleared 21 Nov 2014

• Metafix Blp Plate, Size 31, Left, Metafix Blp Plate, Size 31, Right

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  FDA 510(k) K132226 Active Cleared 9 Aug 2013

• Merete Locking Bone Plate System III

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• Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System

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• Merete Locking Bone Plate System

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  FDA 510(k) K090063 Active Cleared 22 Apr 2009

See all devices from Merete Medical GmbH →

• What is the Intrablock Bioball Hip System used for?

  The Intrablock Bioball Hip System is indicated for use in total hip replacement surgeries. It is specifically designed to support both primary and revision arthroplasty procedures where a cementless fixation approach is required.

• What components are included in the Intrablock Bioball Hip System?

  This modular system consists of several distinct components necessary for hip reconstruction, including femoral stems, femoral heads, taper adapter sleeves, and acetabular cups, allowing for customization during the surgical procedure.

• Has the Intrablock Bioball Hip System received regulatory clearance?

  Yes, the Intrablock Bioball Hip System has received FDA 510(k) clearance under the reference number K123619, confirming it has been found substantially equivalent to predicate devices for its intended use in orthopedic surgery.