(748 days)
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Not Found
No
The summary describes a synthetic bone substitute material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device functions as a bone void filler and synthetic bone substitute, aiding in the healing process by gradually being replaced by bone. It does not actively treat a disease or condition itself, but rather provides structural support during recovery from osteotomies.
No
The device is described as a bone void filler and synthetic bone substitute, intended to be implanted and replaced by bone during healing. It does not perform any diagnostic function.
No
The device description clearly states that Duowedge is a calcium phosphate ceramic, a synthetic bone substitute, which is a physical material and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The description clearly states that Duowedge is a "bone void filler" and a "synthetic bone substitute" intended to be implanted directly into the body (specifically, tibial osteotomies) to aid in bone healing. It is a physical implant, not a device used to analyze samples outside of the body.
Therefore, Duowedge falls under the category of an implantable medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in tibial osteotomies. Duowedge is to be used in combination with adequate post-operative immobilization.
Product codes
MQV
Device Description
The calcium phosphate ceramic Duowedge manufactured by KASIOS is designed to be used as a bone void filler tibial osteotomies. Duowedge is a synthetic bone substitute. It is a macroporous bioceramic, made of hydroxyapatite and beta tricalcium prosphate. When . it is nony site, Duowedge gradually and partially resorbs and is replaced with bone during the healing process. In addition, Duowedge is intended to be used with appropriate opening osteotomy system devices, plates and screws. Duowedge is for use in combination with adequated postoperative immobilization.
Materials: Biphasic porous ceramic composed of hydroxyapatite Ca10(PO4)6(OH)2 and tricalcium phosphate Ca3(PO4)2. These calcium phosphates are manufactured and controlled by (asios in compliance with ASTM F 1185 and ASTM F 1088 standards
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tibial osteotomies
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
510(k) Summarv for Duowedge
DEC - 1 2009
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for Duowedge.
Date Prepared: February 13, 2009
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- Submitter: Kasios
Z.I. La Croix - 8, impasse de la Feuilleraie 31140 Launaguet France
- Submitter: Kasios
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
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- Trade name: Duowedge Bone Substitute Common Name: bone substitute Classification Name: Resorbable Calcium Salt Bone Void Filler Per CFR section 888.3045 Class II MQV
- ്റ് Predicate or legally marketed devices which are substantially equivalent: Duowedge is substantially equivalent to similar previously cleared bone substitutes
র্বা Description of the device:
The calcium phosphate ceramic Duowedge manufactured by KASIOS is designed to be used as a bone void filler tibial osteotomies. Duowedge is a synthetic bone substitute. It is a macroporous bioceramic, made of hydroxyapatite and beta tricalcium prosphate. When . it is nony site, Duowedge gradually and partially resorbs and is replaced with bone during the healing process. In addition, Duowedge is intended to be used with appropriate opening osteotomy system devices, plates and screws. Duowedge is for use in combination with adequated postoperative immobilization.
Materials:
Biphasic porous ceramic composed of hydroxyapatite Ca10(PO4)6(OH)2 and tricalcium phosphate Ca3(PO4)2. These calcium phosphates are manufactured and controlled by (asios in compliance with ASTM F 1185 and ASTM F 1088 standards
5. Intended Use:
When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in thiai osteotomies. Duowedge in combination with adequate post-operative immobilization.
Comparison of the technological characteristics of the device to predicate and legally 6. marketed devices:
Duowedge has the same indications and material, and similar designs as previously cleared devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC - 1 2009
Kasios % The OrthoMedix Group, Inc. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K073214
Trade/Device Name: Duowedge Synthetic Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 8, 2009 Received: September 9, 2009
Dear J.D. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
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Page 2 - J.D. Webb
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K073214
Device Name: Duowedge
Indications for Use:
When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in tibial osteotomies. Duowedge is to be used in combination with adequate post-operative immobilization.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kallum V.M. Egan FOR M.MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K073214
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