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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Pioneer FortrOss Bone Void Filler. This document describes the device, its intended use, and its substantial equivalence to other marketed devices. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically found for medical imaging or diagnostic AI devices.

The 510(k) process for devices like bone void fillers primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against quantitative acceptance criteria through a specific clinical study with established ground truth, specific sample sizes, or expert adjudication as one would for an AI diagnostic tool.

Therefore, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: This type of data is not required for a 510(k) submission for a bone void filler focusing on substantial equivalence. Performance is typically demonstrated through bench testing and comparison to predicates.
Sample sizes used for the test set and the data provenance: Not relevant in this 510(k) context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant.
Adjudication method for the test set: Not relevant.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not relevant as this is a medical device (bone void filler), not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant.
The sample size for the training set: Not relevant as there is no mention of a "training set" in the context of an AI/ML model for this device.
How the ground truth for the training set was established: Not relevant.

The primary "proof" of the device meeting acceptance criteria in a 510(k) for a bone void filler comes from:

Demonstrating "substantial equivalence" to legally marketed predicate devices. The text states: "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." This substantial equivalence is based on similar composition, performance characteristics (presumably assessed through bench testing and material properties), and intended use.
Meeting the general controls and special controls for Class II devices. These are regulatory requirements that all such devices must satisfy, including aspects like good manufacturing practices (GMP), labeling requirements, and any specific performance standards defined for the product code MQV (Resorbable calcium salt bone void filler device).

The study that proves the device meets acceptance criteria, in this context, is the 510(k) submission itself, which presents evidence (likely bench testing, materials characterization, and literature review) to support its substantial equivalence claim. No specific "study" with a "test set," "ground truth," or "expert adjudication" as defined in the prompt (which is typical for AI/ML device evaluations) is detailed because this is not an AI diagnostic device.

Summary

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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 Technology375 River Park CircleMarquette, MI 49855
	Telephone:	+1 (906) 226-4812
	Fax:	+1 (906) 226-4459
Official Contact:	Jonathan Gilbert
Representative/Consultant:	David J. Collette, MDFloyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San 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 Compound21 CFR 880.3045Class II (special controls)
Product Code:	MQV
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Reviewing Branch:	Restorative Devices Branch

email:

flarson@paxmed.com

INTENDED USE

pg 1 of 2

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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

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

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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

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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

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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:

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

Regulation Number and Section

§ 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.