MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; MASTERGRAFT® Strip can also be used with autograft as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e.,the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Putty resorbs and is replaced with bone during the healing process.

Device Description

MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% ß-tricalcium phosphate formulation. MASTERGRAFT® Strip is supplied sterile in a premixed strip form for single patient use.

MASTERGRAFT® Strip is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects.

MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. MASTERGRAFT® Putty is biocompatible. MASTERGRAFT® Putty readily absorbs bone marrow aspirate and has been shown to heal bone defects.

The purpose of this Change Being Effected 510(k) is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Strip and MASTERGRAFT® Putty devices.

AI/ML Overview

This document is a 510(k) summary for a medical device called MASTERGRAFT® (Strip and Putty). The purpose of this 510(k) is to add a new contraindication to the Instructions for Use (IFU).

Therefore, the submission demonstrates substantial equivalence by showing that the subject devices are identical to previously cleared predicate devices in several categories, rather than proving a new performance against acceptance criteria for a novel device. As such, many of the typical acceptance criteria and study design elements requested (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.

Here's the information that can be extracted based on the provided text, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" and "reported device performance" are based on demonstrating substantial equivalence to predicate devices, focusing on the identity of technological characteristics.

Acceptance Criterion (for Substantial Equivalence to Predicate)	Reported Device Performance (Subject Device vs. Predicate)
Indication for Use	Identical
Fundamental Scientific Technology (Operating Principle, Mechanism of Action)	Identical
Basic Design	Identical
Performance	Identical
Sterilization	Identical
Shelf-Life	Identical
Packaging	Identical
Use of rigid fixation	Identical
Safety and Effectiveness profile	Identical
Material Components	Identical
Biocompatibility	Identical

2. Sample size used for the test set and the data provenance

Not applicable. This 510(k) is a "Change Being Effected" for adding a new contraindication. No new clinical performance data from a "test set" was generated or reported for the purpose of demonstrating substantial equivalence for this specific submission. The established performance of the predicate device (which is deemed identical to the subject device) would have been based on prior studies. The document states: "No new non-clinical testing was performed or submitted in support of this 510(k)." The referenced animal studies for the original predicate devices are documented, but these are not "test sets" in the context of an AI/human performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new "ground truth" was established for a test set in this submission. This is not a study involving expert assessment of a new device's output.

4. Adjudication method for the test set

Not applicable. There was no "test set" or adjudication process described as part of this 510(k) submission for demonstrating new performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bone void filler, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical bone void filler, not an algorithm.

7. The type of ground truth used

Not applicable. As established, this submission relies on demonstrating substantial equivalence to predicates, not on generating new performance data against a "ground truth" for a novel device or algorithm. The performance of the predicate devices would have been established through methods like animal models (as referenced in Table 4: Ovine Femoral Defect Model, Rabbit Lumbar Intertransverse Process Fusion Model, Ovine Cortico-cancellous Defect Model for "in-vivo performance comparison" and "fusion results").

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a training set.

Summary

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APR 1 8 2014

510(K) Summary

I. SUBMITTER NAME & ADDRESSS:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738Establishment Registration: 1030489
CONTACT PERSON:	Kelly AnglinSenior Regulatory Affairs Specialist
DATE PREPARED:	April 02, 2014
II. PROPOSED PROPRIETARY TRADE NAME:	MASTERGRAFT® StripMASTERGRAFT® Putty
DEVICE CLASSIFICATION NAME:	Resorbable Calcium Salt Bone Void Filler
REGULATION NUMBER:	21 CFR 888.3045
CLASSIFICATION PRODUCT CODE:	MQV
CLASS:	II

III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:

Table 1. Legally Marketed Devices
Device name	510(k) number	Substantial Equivalence date
MASTERGRAFT® Strip	K082166	06/02/2009
MASTERGRAFT® Putty	K071813	11/09/2007

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IV. DEVICE DESCRIPTION: MASTERGRAFT® STRIP

MASTERGRAFT® Putty

The purpose of this Change Being Effected 510(k) is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Strip and MASTERGRAFT® Putty devices.

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V. INDICATIONS FOR USE:

MASTERGRAFT® Strip

MASTERGRAFT® PUTTY

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Table 2. Summary of the technological Characteristics
Comparison Feature	SubjectMASTERGRAFT® StripK082166 S.E. 06/02/2009	Predicate MASTERGRAFT® Strip
Indication for Use	Identical	K082166 S.E. 06/02/2009
FundamentalScientific Technology• OperatingPrinciple• Mechanism ofAction	Identical	K082166 S.E. 06/02/2009
Basic Design	Identical	K082166 S.E. 06/02/2009
Performance	Identical	K082166 S.E. 06/02/2009
Sterilization	Identical	K082166 S.E. 06/02/2009
Shelf-Life	Identical	K082166 S.E. 06/02/2009
Packaging	Identical	K082166 S.E. 06/02/2009
Use of rigid fixation	Identical	K082166 S.E. 06/02/2009
Safety andEffectiveness profile	Identical	K082166 S.E. 06/02/2009

VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

and the same of the same

Table 3. Summary of the technological Characteristics
Comparison Feature	SubjectMASTERGRAFT® PuttyK071813 S.E. 11/09/2007	Predicate MASTERGRAFT®Putty
Indication for Use	Identical	K071813 S.E. 11/09/2007
FundamentalScientific Technology• OperatingPrinciple• Mechanism ofAction	Identical	K071813 S.E. 11/09/2007
Basic Design	Identical	K071813 S.E. 11/09/2007
Performance	Identical	K071813 S.E. 11/09/2007
Sterilization	Identical	K071813 S.E. 11/09/2007
Shelf-Life	Identical	K071813 S.E. 11/09/2007
Packaging	Identical	K071813 S.E. 11/09/2007
Use of rigid fixation	Identical	K071813 S.E. 11/09/2007
Safety andEffectiveness profile	Identical	K071813 S.E. 11/09/2007

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VII. DISCUSSION OF NON-CLINICAL TESTING:

Non-clinical testing was performed in support of substantial equivalence for the cited predicates K082166 and K071813 in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k).

Table 4. Non-clinical testing
Cleared Device	Animal Model	Study Purpose	SubstantialEquivalence
MASTERGRAFT®Strip	Ovine FemoralDefect Model	In-vivo performancecomparison	MASTERGRAFT®Matrix (K023553 S.E.04/22/2003)
	Rabbit LumbarIntertransverseProcess FusionModel	Fusion resultsMASTERGRAFT®Strip + autograft asbone graft extendercompared toautograft fusionresults	Equivalent to autograftfusion results
MASTERGRAFT®Putty	Ovine Cortico-cancellous DefectModel	In-vivo performancecomparison	HEALOS® BoneGraft Material(K012751 S.E.11/14/2001)
	Rabbit LumbarIntertransverseProcess FusionModel	Fusion resultsMASTERGRAFT®Putty + autograft asbone graft extendercompared toautograft fusionresults	Equivalent to autograftfusion results

VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject devices are substantially equivalent to the previously cleared MASTERGRAFT® Strip (K082166 S.E. 06/02/2009) and MASTERGRAFT® Putty (K071813 S.E. 11/09/2007) devices. The

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subject devices are substantially equivalent to predicates in several categories including: indication, material components, sterility, shelf-life, and biocompatibility.

、

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

April 18, 2014

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

Re: K140375

Trade/Device Name: MASTERGRAFT® Strip; MASTERGRAFT® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 13, 2014 Received: February 14, 2014

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

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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.

Lori A. Wiggins

for

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

Enclosure

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510(k) Number (if known): K140375

Device Name: MASTERGRAFT® Strip

INDICATIONS FOR USE:

MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Prescription Use _____________________________________________________________________________________________________________________________________________________________	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(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

: 上

Page 1 of 2

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140375

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510(k) Number (if known): K140375

Device Name: MASTERGRAFT® Putty

INDICATIONS FOR USE:

MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, ilium, and/or extremities). These defects may be surgically created osseous defects or usseous defects created from traumatic injury to the bone. MASTERGRAFT® Putty resorbs and is replaced with 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 2 of 2

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140375

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.