(19 days)
Not Found
No
The summary describes a bone void filler material and its intended use, with no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is a bone void filler used for repair or augmentation of bony contours, rather than actively treating a disease or condition.
No
The device, OsteoVation CMF Bone Void Filler, is indicated for the repair or filling of bone voids and restoration/augmentation of bony contours, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "calcium phosphate bone void filler," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a bone void filler for surgical repair and augmentation of craniofacial defects. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description confirms it's a material injected or impacted into a void, consistent with a surgical implant or filler.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting diseases, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.
Product codes (comma separated list FDA assigned to the subject device)
FWP, GXP
Device Description
OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, including fronto-orbital, malar, and mental areas
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
JUL 20 2005
510(k) Summary
Skeletal Kinetics, LLC OsteoVation™ CMF Bone Void Filler
| General Information | |
|---|---|
| Submitters Name/Address: | Skeletal Kinetics |
| 10201 Bubb Road | |
| Cupertino, CA 95014 | |
| Establishment Registration Number: | 3003890476 |
| Contact Person: | Duran Yetkinler |
| Vice President, Product Development | |
| and Regulatory Affairs | |
| Phone Number: | (408) 366.5002 |
| Date Prepared: | June 30, 2005 |
| Device Description | |
| Trade Name: | OsteoVation CMF Bone Void Filler |
| Generic/Common Name: | Hydroxyapatite Cement |
| Classification Name: | 84 GXP |
| Predicate Devices | |
| Callos Bone Void Filler | |
| Callos CMF Bone Void Filler | K051123; cleared on June 3, 2005 |
| K042072; cleared on Sept. 16, 2004 |
Product Description
OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
Intended Use
OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.
1
Substantial Equivalence
This Special 510(k) proposes a modification in materials for Osteo Vation, which was previously cleared under K042072 on June 3, 2005. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Osteo Vation remain the same as in the predicate cleared 510(k)s.
Summary of Safety and Effectiveness
OsteoVation, as described in this submission, is substantially equivalent to the predicate, unmodified Callos CMF. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of OsteoVation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, rendered in a simple, abstract design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2005
Duran Yetkinler, M.D. Ph.D. Vice President, Product Development and Regulatory Affairs 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Skeletal Kinetics, LLC 10201 Bubb Road Cupertino, California 95014
Re: K051784
Trade/Device Name: OsteoVation™ CMF Bone Void Filler Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: FWP, GXP Dated: June 30, 2005 Received: July 1, 2005
Dear Dr. Yetkinler:
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 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 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); 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.
3
Page 2 - Duran Yetkinler, M.D. Ph.D
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 (240) 276-0120. 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,
Erik. Th
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known)
OsteoVation™ CMF Bone Void Filler Device Name:
Indications for use:
OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) AND/OR
X
Over-the-Counter Use (21 CFR 801 Subpart C)
Signature
on of General, Restorative rolos
J2C(c) Number K051784