(49 days)
Not Found
No
The device description focuses on the material composition and physical properties of a bone void filler, with no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML.
Yes
This device is a bone void filler intended for use in the treatment of osseous defects, which is a therapeutic function.
No
Explanation: The device is described as a bone void filler intended for use in the treatment of osseous defects, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical implant made of synthetic materials (beta tri-calcium phosphate and hydroxyapatite) in the form of granules and sticks. It is a physical bone void filler, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Ceraform Bone Void Filler is for filling voids or gaps in the skeletal system during surgical procedures. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a physical implant made of synthetic materials designed to be placed within the body to aid in bone healing. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
Therefore, Ceraform Bone Void Filler is a medical device used for surgical intervention and bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium phosphate(30% - 40%) and hydroxyapatite (60% - 70%). It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60% - 85% and the size of pores is 150 - 400μm. Ceraform implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone. Ceraform is available in 5 gram, 10 gram and 15 grams dosages of granules that are approximately 3mm X 3mm in size, and sticks of packages of 5 and 10 units that are 5mm X 5mm X 20mm in size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, spine, and pelvis)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Date March 9, 2004
Submitter
Teknimed, S.A. 11 rue Apollo 31240 L'Union FRANCE
Contact person
J.D. Wcbb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Bone void filler
Classification name
Filler, calcium sulfate, preformed pellets per 21 CFR Sec. 888.3045
Equivalent Device
Ceraform Bone Void Filler is a modification to Teknimed's TRIHA+ Bone Void Filler (K031826).
MAY - 3 2004
Device Description
Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium phosphate(30% - 40%) and hydroxyapatite (60% - 70%). It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60% - 85% and the size of pores is 150 - 400μπ. Ceraform implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone.
Ceraform is available in 5 gram, 10 gram and 15 grams dosages of granules that are approximately 3mm X 3mm in size, and sticks of packages of 5 and 10 units that are 5mm X 5mm X 20mm in size.
Intended Use
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Summary of Technological Characteristics Compared to Predicate Device
Ceraform is similar to the predicate device in terms of composition, porosity, pore size, and resorption.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle. The eagle is facing to the right and has its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Teknimed, S.A. C/o Mr. J. D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K040669
Trade/Device Name: Ceraform Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: April 20, 2004 Received: April 22, 2004
Dear Mr. 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 cnactment 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 r ou may, aroney interest 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 such 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 Fedcral 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. J. D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letet notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark A. Millman
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040669
Device Name: Ceraform Bone Void Filler
Indications for Use:
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontancously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Countor 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)
Mark N. Millerson
ion-()f Division of General, Restorative, and Neurological Devices
510(k) Number K040669