Skip to content

CAP3 Bone Substitute Material

by Etex Corp.

510(k) K033138

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033138 Date2 Dec 2003ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQV
Device class
Class II
Regulation
21 CFR Part 888.3045
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).

Other devices from Etex Corp.

See all devices from Etex Corp. →