(203 days)
Pioneer E-Matrix Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Pioneer E-Matrix Bone Void Filler is a gelatin-based bone void filler for use in repairing bony defects in the extremities and pelvis that are not intrinsic to the stability of the bony structure. The product is provided sterile, for single use only, and is supplied in granular form to be reconstituted at the time of use. A commercially available dispensing syringe and a mixing spatula are included in the product package.
The provided document is a 510(k) summary for the Pioneer E-Matrix Bone Void Filler. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert ground truth establishment, adjudication methods, or MRMC/standalone studies.
The document primarily focuses on:
- Device Description and Intended Use: Explains what the Pioneer E-Matrix Bone Void Filler is and what it's used for.
- Predicate Devices: Lists existing devices to which the Pioneer E-Matrix Bone Void Filler claims substantial equivalence.
- Substantial Equivalence Conclusion: States that comparisons and testing demonstrate substantial equivalence to other bone void fillers.
- FDA Communication: The FDA letter confirms the 510(k) clearance based on substantial equivalence, outlines regulatory requirements, and includes the official Indications for Use.
In summary, this document does not describe a study with acceptance criteria and measured performance in the way a clinical trial or algorithm validation study would. It's a regulatory document for clearance based on equivalence, not a direct performance report.
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510(k) Summary
510(k) Summary Pursuant to 21 CFR 807
- Pioneer Surgical Technology 1. Submitted By: 375 River Park Circle Marquette, MI 49855 Jon Gilbert 2. Contact: Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855 (906) 226-4812 3. Product: Pioneer E-Matrix Bone Void Filler
JUN 1 2 2009
CFR Section 880.3045 Resorbable Calcium Salt Bone Void Filler Device Class II (special controls) Product Code: MOV
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- Common/Trade Name:
Filler, Bone Void, Calcium Compound Pioneer E-Matrix Bone Void Filler
- Common/Trade Name:
Description:
Pioneer E-Matrix Bone Void Filler is a gelatin-based bone void filler for use in repairing bony defects in the extremities and pelvis that are not intrinsic to the stability of the bony structure. The product is provided sterile, for single use only, and is supplied in granular form to be reconstituted at the time of use. A commercially available dispensing syringe and a mixing spatula are included in the product package.
Intended Use/Indication:
Pioneer E-Matrix Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Substantial Equivalence:
Pioneer E-Matrix Bone Void Filler is comparable to Bone Void Filler devices already on the market in several characteristics which may include indications, porcine gelatin carrier, and presentation.
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Devices to Which Substantial Equivalence is Claimed:
K081558 - NanOss Bone Void Filler
K032288 – Vitoss Scaffold Foam Bone Graft Material
K071187 – MicroFuse Bone Void Filler
Conclusions:
The comparisons and testing conducted on Pioneer E-Matrix Bone Void Filler demonstrate that the device is substantially equivalent to other bone void fillers currently in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pioneer Surgical Technology % Mr. Jonathan M. Gilbert Vice President, Regulatory & Clinical Affairs 375 River Place Circle Marquette, Michigan 49855
JUN 1 2 2009
Re: K083449
Trade/Device Name: Pioneer E-Matrix Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium sait bone void filler device Regulatory Class: II Product Code: MQV Dated: June 4, 2009 Received: June 9, 2009
Dear Mr. Gilbert:
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 T 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 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. 1
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Page 2- Mr. Jonathan M. Gilbert
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Charlene buchner
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: K083449
Device Name: Pioneer E-Matrix Bone Void Filler
Indications for Use:
Pioneer E-Matrix Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Yumart. C. Coper
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083449
X Prescription Use (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)
§ 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.