Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material composition and biological function of a bone graft substitute, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a bone graft substitute, intended to facilitate bone healing by providing a scaffold for new bone growth, rather than directly treating a disease or condition in a therapeutic manner.

Diagnostic

No.
The device is a bone graft substitute intended to treat bony voids or gaps, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an implant assembled from human bone allograft tissue matrix, autograft tissue, and a resorbable mesh bag, along with disposable plastic instruments. This indicates a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is as a bone graft substitute in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
Device Description: The device is a physical implant assembled from bone tissue and a resorbable mesh bag, used to fill bony voids. This is a surgical implant, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
Anatomical Site: The device is used directly within the skeletal system, not for testing samples taken from the body.

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.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Product codes (comma separated list FDA assigned to the subject device)

MQV, MBP

Device Description

The implant in the subject device kit for MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied accessories included in the kit that consist of disposable plastic instruments spatula, funnel, and plunger. The resorbable mesh bag provides containment of the allograft/autograft mixture to prevent migration of the grafting material.

The allograft component of the predicate MAGNIFUSE® Bone Graft K123691 (S.E. 01/31/2013) and subject MAGNIFUSE® II Bone Graft is comprised of processed human cortical allograft bone particles. The particles consist of demineralized bone matrix (DBM) in a fiber form as an osteoinductive component combined with non-demineralized cortical fibers as the osteoconductive component. The allograft bone is derived from human tissue recovered in the U.S. by FDA registered tissue bank establishments. The tissue is recovered from a cadaveric donor using aseptic surgical techniques and has been microbiologically tested during recovery. Incoming donor bone tissue is subjected to various screening and testing requirements before it is released for processing in accordance with FDA requirements for donor suitability/eligibility. The final product in packaged form is tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard .

The purpose of this 510(k) application is to modify the current composition, the ratio and processing technique of the allograft component contained in the subject MAGNIFUSE® II Bone Graft device to improve donor utilization. These proposed modifications to the allograft component are identical to the predicate MAGNIFUSE® Bone Graft K123691 (S.E. 01/31/2013). Refer to Table 2 below for the summary of the technological characteristics related to the allograft component contained in the subject device. All other aspects of the subject MAGNIFUSE® II Bone Graft device are identical to the predicate MAGNIFUSE® II Bone Graft K122513 (S.E. 03/06/2013) device with the exception of the changes to the allograft component mentioned above. Refer to Table 3 below for the summary of the technological characteristics. The detailed descriptions are outlined in the substantial equivalence discussion section of this 510(k).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinician

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 testing was performed in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. A rabbit posterolateral lumbar spinal fusion study was conducted to evaluate the bone formation capabilities of the subject device related to the proposed allograft formulation change from cortical bone chips/fibers to cortical bone fiber/fiber formulation. The manual palpation and radiographic results for the subject device demonstrates equivalency to the predicate MAGNIFUSE® Bone Graft device K123691 (S.E. 01/31/2013). The complete test report and summary can be found in the Animal Performance Testing section of this application.

The allograft component of the subject device will be processed via a proprietary processing method that has been shown to consistently produce demineralized bone matrix that is osteoinductive in an athymic rat assay. Like the predicate MAGNIFUSE® Bone Graft device K123691 (S.E. 01/31/2013), the tissue processing of the subject will be confirmed via ongoing testing of finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0, 1, 2, 3, 4) to score bone formation at 28 days post implantation*. Bone formation in the athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.

Viral inactivation of the demineralized fibers in the subject MAGNIFUSE® II Bone Graft device includes proprietary processing steps of demineralizing acid soaks followed by alcohol soaks and dehydration. Viral inactivation of the non-demineralized cortical fibers in the subject device is provided by alcohol soaks and by dehydration using supercritical CO2. These processing steps that have been shown and validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus. These processes further reduce the risk of disease transmission via the use of this product beyond the protection provided by donor testing and screening procedures.

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.

K123691, K122513

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

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.

Summary

0

!

510(K) Summary

| SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738
Establishment Registration: 1030489 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OCT 0 3 2013 | |
| CONTACT PERSON: | Kelly Anglin
Senior Regulatory Affairs Specialist |
| DATE PREPARED: | October 02, 2013 |

II. PROPOSED PROPRIETARY TRADE NAME: MAGNIFUSE® II Bone Graft

DEVICE CLASSIFICATION NAME:	Resorbable Calcium Salt Bone Void Filler
REGULATION NUMBER:	21 CFR 888.3045
CLASSIFICATION PRODUCT CODE:	MQV, MBP
CLASS:	II

III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:

Table I. LEGALLY MARKETED DEVICES
Device name	510(k) number	Substantial Equivalence date
MAGNIFUSE® Bone Graft	K 123691	01/31/2013
MAGNIFUSE® II Bone Graft K122513		03/06/2013

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K131673 Page 2 of 5

IV. DEVICE DESCRIPTION:

The implant in the subject device kit for MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied accessories included in the kit that consist of disposable plastic instruments spatula, funnel, and plunger. The resorbable mesh bag provides containment of the allograft/autograft mixture to prevent migration of the grafting material.

The allograft component of the predicate MAGNIFUSE® Bone Graft K123691 (S.E. 01/31/2013) and subject MAGNIFUSE® II Bone Graft is comprised of processed human cortical allograft bone particles. The particles consist of demineralized bone matrix (DBM) in a fiber form as an osteoinductive component combined with non-demineralized cortical fibers as the osteoconductive component. The allograft bone is derived from human tissue recovered in the U.S. by FDA registered tissue bank establishments. The tissue is recovered from a cadaveric donor using aseptic surgical techniques and has been microbiologically tested during recovery. Incoming donor bone tissue is subjected to various screening and testing requirements before it is released for processing in accordance with FDA requirements for donor suitability/eligibility. The final product in packaged form is tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard .

The purpose of this 510(k) application is to modify the current composition, the ratio and processing technique of the allograft component contained in the subject MAGNIFUSE® II Bone Graft device to improve donor utilization. These proposed modifications to the allograft component are identical to the predicate MAGNIFUSE® Bone Graft K123691 (S.E. 01/31/2013). Refer to Table 2 below for the summary of the technological characteristics related to the allograft component contained in the subject device. All other aspects of the subject MAGNIFUSE® II Bone Graft device are identical to the

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K131673 Page 3 of 5

predicate MAGNIFUSE® II Bone Graft K122513 (S.E. 03/06/2013) device with the exception of the changes to the allograft component mentioned above. Refer to Table 3 below for the summary of the technological characteristics. The detailed descriptions are outlined in the substantial equivalence discussion section of this 510(k).

V. INDICATIONS FOR USE:

MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

| Comparison Feature | Subject
MAGNIFUSE® II Bone
Graft | Predicate MAGNIFUSE®
Bone Graft (K123691 S.E.
01/31/2013) |
|-----------------------------------------------------------------------------------------------|----------------------------------------|-----------------------------------------------------------------|
| Allograft component
Demineralized Bone Matrix (DBM) in fiber form Non-demineralized fibers | Identical | K123691 S.E. 01/31/2013 |
| Allograft Ratio | Identical | K123691 S.E. 01/31/2013 |
| Processing Method of DBM
fibers | Identical | K123691 S.E. 01/31/2013 |

VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

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Table 3: Summary of the technological Characteristics
Comparison Feature	Subject
MAGNIFUSE® II Bone
Graft	Predicate MAGNIFUSE® II Bone
Graft (K122513 S.E. 03/06/2013)
Indication for Use	Identical	K122513 S.E. 03/06/2013
Fundamental
Scientific Technology
• Operating
Principle
• Mechanism of
Action	Identical	K122513 S.E. 03/06/2013
Basic Design	Identical	K122513 S.E. 03/06/2013
Performance	Identical	K122513 S.E. 03/06/2013
Sterilization	Identical	K122513 S.E. 03/06/2013
Shelf-Life	Identical	K122513 S.E. 03/06/2013
Packaging	Identical	K122513 S.E. 03/06/2013
Use of rigid fixation	Identical	K122513 S.E. 03/06/2013
Safety and
Effectiveness profile	Identical	K122513 S.E. 03/06/2013
PGA Mesh bag
Closure Mechanism	Identical	K122513 S.E. 03/06/2013

VII. DISCUSSION OF NON-CLINICAL TESTING:

Non-clinical testing was performed in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. A rabbit posterolateral lumbar spinal fusion study was conducted to evaluate the bone formation capabilities of the subject device related to the proposed allograft formulation change from cortical bone chips/fibers to cortical bone fiber/fiber formulation. The manual palpation and radiographic results for the subject device demonstrates equivalency to the predicate MAGNIFUSE® Bone Graft device K123691 (S.E. 01/31/2013). The complete test report and summary can be found in the Animal Performance Testing section of this application.

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The allograft component of the subject device will be processed via a proprietary processing method that has been shown to consistently produce demineralized bone matrix that is osteoinductive in an athymic rat assay. Like the predicate MAGNIFUSE® Bone Graft device K123691 (S.E. 01/31/2013), the tissue processing of the subject will be confirmed via ongoing testing of finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0, 1, 2, 3, 4) to score bone formation at 28 days post implantation*. Bone formation in the athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.

Edwards etal; Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model. Clinical Orthopaedics, December 1998, Vol 357.

Viral inactivation of the demineralized fibers in the subject MAGNIFUSE® II Bone Graft device includes proprietary processing steps of demineralizing acid soaks followed by alcohol soaks and dehydration. Viral inactivation of the non-demineralized cortical fibers in the subject device is provided by alcohol soaks and by dehydration using supercritical CO2. These processing steps that have been shown and validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus. These processes further reduce the risk of disease transmission via the use of this product beyond the protection provided by donor testing and screening procedures.

VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared MAGNIFUSE® Bone Graft device K 123691 (S.E. 01/31/2013) for the allograft component and MAGNIFUSE® II Bone Graft K122513 (S.E. 03/06/2013) for all other aspects of the subject device.

The subject device is substantially equivalent to predicate MAGNIFUSE® II Bone Graft in several categories including: indication, material components, sterility, shelf-life, and biocompatibility.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2013

Medtronic Sofamor Danek USA, Incorporated Ms. Kelly Anglin Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K131673

Trade/Device Name: MAGNIFUSE® II Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: August 14, 2013 Received: August 16, 2013

Dear Ms. Anglin:

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.

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

Image /page/5/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is bolded. The image is in black and white.

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Page 2 - Ms. Kelly Anglin

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/7/Picture/0 description: The image shows a handwritten string of characters, seemingly a code or identifier. The characters are 'K131673', written in a cursive style with thick, dark strokes. The handwriting is clear and legible, with each character distinct and easily identifiable.

510(k) Number (if known):

Device Name: MAGNIFUSE® II Bone Graft

INDICATIONS FOR USE:

MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

Page 1 of 1

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131673