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Bio2 CLM BG Bioactive Scaffold

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142463

by Bio2 Technologies, Inc.

Identifiers

510(k) Number
K142463 FDA 510(k)
FDA Product Code
MQV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bio2 CLM BG Bioactive Scaffold is a synthetic, non-collagenous, osteoconductive bone void filler classified as an orthopedic device. It consists of bioactive glass fibers designed to support bone regeneration and facilitate tissue integration within skeletal voids, including extremities and the pelvis.

This device is supplied as sterile cylinders, blocks, or wedges and is intended for surgical implantation by orthopedic specialists. It is a Class II medical device with FDA 510(k) clearance under K152589, granted as substantially equivalent to a predicate device. Storage and handling must comply with sterile medical device protocols, as specified by the manufacturer.

Frequently asked questions

What types of shapes and sizes are available for the Bio2 CLM BG Bioactive Scaffold, and how might this affect my surgical planning?

The Bio2 CLM BG Bioactive Scaffold is supplied as sterile cylinders, blocks, or wedges, allowing flexibility to match the anatomical void or defect being treated. These shapes are designed to fit skeletal voids in extremities or the pelvis, supporting bone regeneration and tissue integration. The specific dimensions are not detailed in the provided data, but the variety of forms should accommodate most common orthopedic applications where osteoconductive support is needed.

Is the Bio2 CLM BG Bioactive Scaffold intended for single-use only, or can it be reused after sterilization?

The Bio2 CLM BG Bioactive Scaffold is supplied as a sterile product, which implies it is intended for single-use only. Reusing medical devices, especially those classified as orthopedic implants, is not recommended unless explicitly stated by the manufacturer. Sterility protocols must be strictly followed during storage and handling to ensure patient safety, as outlined in the manufacturer’s guidelines.

How should the Bio2 CLM BG Bioactive Scaffold be stored to maintain its sterility and integrity before use?

Since the Bio2 CLM BG Bioactive Scaffold is provided in a sterile form, it must be stored according to sterile medical device protocols. This typically involves keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. The manufacturer’s instructions should be consulted for specific storage conditions to preserve sterility and prevent degradation before surgical use.

What is the primary purpose of the Bio2 CLM BG Bioactive Scaffold, and what types of patients or procedures would benefit from it?

The Bio2 CLM BG Bioactive Scaffold is designed as an osteoconductive bone void filler to support bone regeneration and tissue integration within skeletal voids. It is intended for surgical implantation by orthopedic specialists, particularly in cases involving defects in extremities or the pelvis where bone reconstruction is required. It is not intended for any specific patient population but is tailored for procedures where a synthetic, non-collagenous scaffold is needed to aid healing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bio2 CLM BG Bioactive Scaffold (K152589) — FDA 510 (k) | Innolitics, Bio2 CLM BG Bioactive Scaffold — FDA 510 (k) K152589 | MedTracker, Bio2 CLM BG Bioactive Scaffold - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio2 Technologies, Inc.

Sources (1)

  • FDA 510(k) K142463 24 fields · synced Sep 19, 2026