(60 days)
Not Found
No
The summary describes a resorbable bone void filler material and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a bone void filler that resorbs and is replaced with bone during the healing process, indicating a therapeutic function to aid in bone repair.
No
The device is described as a "bone void filler" used in surgical procedures to fill gaps in bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a resorbable bone void filler consisting of calcium phosphate and porcine gelatin, which are physical materials, 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 the device is a "bone void filler" used to fill bony voids or gaps in the posterolateral spine. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition (calcium phosphate in a porcine gelatin carrier) and form (granular) of the material, which is consistent with a bone graft substitute or filler. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening. FortrOss Bone Void Filler is used in vivo (inside the body) for a structural and regenerative purpose.
N/A
Intended Use / Indications for Use
FortrOss Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
FortrOss Bone Void Filler is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. FortrOss Bone Void Filler is radiopaque, provided sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony voids or gaps that are not intrinsic to the stability of bony structure, posterolateral spine
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)
Non-clinical evaluation consisting of material specifications and engineering design review and validation relevant to the line extensions described above were performed.
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
§ 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
KII0561
Special 510(k): Device Modification
FortrOss Bone Void Filler
APR 2 9 2011
510(k) Summary
Pioneer Surgical Technology Special 510(k): Device Modification
FortrOss Bone Void Filler
ADMINISTRATIVE INFORMATION
Manufacturer Name:
375 River Park Circle Marquette, MI 49855 +1 (906) 226-4812 Telephone: Fax: +1 (906) 226-4459
Pioneer Surgical Technology
Official Contact:
Representative/Consultant:
Jonathan Gilbert
David J. Collette, MD or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: dcollette@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
FortrOss Bone Void Filler Bone Void Filler Filler, Bone Void, Calcium Compound 21 CFR 888.3045, Class II MQV Orthopaedic and Rehabilitation Devices Restorative Devices Branch
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1
Special 510(k); Device Modification
FortrOss Bone Void Filler
INTENDED USE
FortrOss Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
DEVICE DESCRIPTION
FortrOss Bone Void Filler is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. FortrOss Bone Void Filler is radiopaque, provided sterile and is intended for single use only.
PREDICATE DEVICE
K091031 - Pioneer FortrOss Bone Void Filler
COMPARISON TO MARKETED DEVICE
The intended use and composition of this device are identical to those of the predicate. This submission introduces a larger (20 cc) product size, a packaging modification consisting of a mixing chamber intended to facilitate reconstitution of the device at the time of implantation, and an accessory to facilitate placement of the device along the posterolateral spine.
PERFORMANCE TESTING
Non-clinical evaluation consisting of material specifications and engineering design review and validation relevant to the line extensions described above were performed.
CONCLUSION
Based on information presented in this submission, we conclude that the FortrOss Bone Void Filler is substantially equivalent to predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 9 2011
Pioneer Surgical Technology % PaxMed international, LLC David J. Collette, M.D. 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K110561
Trade/Device Name: FortrOss Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: March 31, 2011 Received: April 1, 2011
- Dear Dr. Collette:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - David J. Collette, M.D.
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 (reporting of medical 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/CDRH/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A
B. R
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FortrOss Bone Void Filler
Indications for Use
510(k) Number: K110261
Device Name: FortrOss Bone Void Filler
Indications for Use
FortrOss Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sigr (Division Sign-On), Orthopedia
Division of Surgical, Orthopedia
Devision of Surgical, Devices DIVIsion of Surges
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Page 1 of
510(k) Number .