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CAP3 Bone Substitute Material

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033138

by Etex Corp.

Identifiers

510(k) Number
K033138 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)

CAP3 Bone Substitute Material is a synthetic, biocompatible bone graft substitute classified as a filler for bone voids using a calcium compound. It is supplied as a powder that is mixed with 0.9% sodium chloride at the point of care to form a paste for manual application to bone voids or defects in extremities, spine, or pelvis.

The material hardens at body temperature, converting to poorly crystalline hydroxyapatite (PCHA), which is osteoconductive and resorbed and replaced by new bone. It is provided non-sterile and intended for single-use application. The device received FDA 510(k) clearance (K033138) on December 2, 2003, under product code MQV, and is regulated as a Class II device with special controls.

Frequently asked questions

What is CAP3 Bone Substitute Material used for?

CAP3 Bone Substitute Material is used as a filler for bone voids or defects in extremities, spine, or pelvis. It is mixed with 0.9% sodium chloride to form a paste that is manually applied to the defect site, where it hardens at body temperature to support bone regeneration.

How is CAP3 Bone Substitute Material supplied and prepared for use?

CAP3 Bone Substitute Material is supplied as a non-sterile powder that must be mixed with 0.9% sodium chloride at the point of care to form a paste. This paste is then manually applied to the bone void or defect. It is intended for single-use only after mixing.

Is CAP3 Bone Substitute Material sterile, and can it be reused?

CAP3 Bone Substitute Material is provided non-sterile and is intended for single-use application only. It should not be resterilized or reused, as doing so may compromise its performance and increase the risk of contamination or adverse reactions.

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: K033138 FDA 510(k) - CAP3 BONE SUBSTITUTE MATERIAL | Etex Corp., CAP3 BONE SUBSTITUTE MATERIAL (K033138) — FDA 510(k) | Innolitics, K032307 FDA 510(k) - CAP BONE SUBSTITUTE MATERIAL | Etex Corp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Etex Corp.

Sources (1)

  • FDA 510(k) K033138 24 fields · synced Sep 24, 2026