(221 days)
Not Found
No
The summary describes a material-based bone void filler and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The Intended Use / Indications for Use section states that the device is a "bone void filler that resorbs and is replaced with bone during the healing process," which indicates its role in treating or restoring the body's structure or function.
No
The device is described as a bone void filler used for repairing bony defects, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a porous calcium phosphate material mixed with a porcine gelatin carrier, indicating it 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 clearly states that the device is a "bone void filler" used to repair bony defects in the posterolateral spine. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "porous calcium phosphate material mixed with a porcine gelatin carrier" that acts as an "osteoconductive scaffold." This describes a material implanted into the body to aid in bone healing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pioneer 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
Pioneer FortrOss Bone Void Filler is a porous calcium phosphate material mixed with a porcine gelatin carrier. The product is an osteoconductive scaffold mixed with a gelatin carrier for use in repairing bony defects in spinal indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The comparisons and testing conducted on FortrOss Bone Void Filler demonstrate that the device is substantially equivalent to other bone void fillers currently in commercial distribution.
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.
K081558, K082575, K050798, K032288
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
Pioneer FortrOss Bone Void Filler
510(k) Summary
NOV 1 7 2009
Pioneer Surgical Technology Pioneer FortrOss Bone Void Filler
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855 | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Telephone: | +1 (906) 226-4812 |
| | Fax: | +1 (906) 226-4459 |
| Official Contact: | Jonathan Gilbert | |
| Representative/Consultant: | David J. Collette, MD
Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130 | |
| | Telephone: | +1 (858) 792-1235 |
| | Fax: | +1 (858) 792-1236 |
| | email: | dcollette@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Pioneer FortrOss Bone Void Filler |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Regulations: | Filler, Bone Void, Calcium Compound |
| 21 CFR 880.3045 | |
| Class II (special controls) | |
| Product Code: | MQV |
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Reviewing Branch: | Restorative Devices Branch |
email:
INTENDED USE
Pioneer 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
pg 1 of 2
1
510(k) Summary
・
Pioneer FortrOss Bone Void Filler
provides a bone void filler that resorbs and is replaced with bone during the healing process.
DEVICE DESCRIPTION
Pioneer FortrOss Bone Void Filler is a porous calcium phosphate material mixed with a porcine gelatin carrier. The product is an osteoconductive scaffold mixed with a gelatin carrier for use in repairing bony defects in spinal indications.
EQUIVALENCE TO MARKETED DEVICES
Pioneer FortrOss Bone Void Filler is identical in composition and performance to Pioneer BVF-E cleared (K081558). Predicate devices with similar characteristics, which may include ceramic materials, porcine gelatin carrier, porous structure, and presentation are cited below.
Devices to Which Substantial Equivalence is Claimed:
K081558 - Pioneer Surgical NanOss BVF-E K082575 -- Actifuse™ Bone Graft Substitute K050798 - Formagraft™ Collagen Bone Graft Matrix K032288 -- Vitoss® Scaffold Foam
The comparisons and testing conducted on FortrOss Bone Void Filler demonstrate that the device is substantially equivalent to other bone void fillers currently in commercial distribution.
pg 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 or bird-like figure with flowing lines, positioned to the right. Encircling the figure is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the upper left portion of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology % PaxMed International, LLC David J. Collette, M.D. 11234 El Camino Real, Suite 200 San Diego, CA 92130
NOV 1 7 2009
Re: K091031
Trade/Device Name: Pioneer FortrOss Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 29, 2009 Received: October 30, 2009
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.
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 (reporting of medical
3
Page 2 - David J. Collette, M.D.
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/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 N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Summary
Pioneer FortrOss Bone Void Filler
Indications for Use
510(k) Number: K091031
Device Name: Pioneer FortrOss Bone Void Filler
Indications for Use:
Pioneer 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 (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
H.H.Hilly FOR M.MELKERSON
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091031