ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. AI.LOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine) and as a bone void filler in the extremitics and pclvis. These defects may be surginally created osseous defects or osseous defects created from traumatic injury to the bone.

Device Description

ALLOMATRIX® Custom Putty is provided in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit (or BMA and local bone when used in the spine), the resultant putty cappthen he handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

AI/ML Overview

The provided text describes a 510(k) summary for the ALLOMATRIX® Custom Putty, a bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or a diagnostic device. Therefore, many of the requested categories are not applicable.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance for ALLOMATRIX® Custom Putty

This submission is for a modification to a component of an existing device (ALLOMATRIX® Custom Putty) and focuses on demonstrating substantial equivalence, not on specific performance metrics or diagnostic accuracy as would be typical for an AI application. The "acceptance criteria" here relate to the successful verification that the modification has the desired effect and no unintended adverse effects, primarily through demonstrating substantial equivalence to a predicate device, and the "device performance" is based on these demonstrations.

Acceptance Criteria Category	Reported Device Performance/Findings
Substantial Equivalence	The modified ALLOMATRIX® Custom Putty was found to be substantially equivalent to the predicate device(s).
Literature Search	Used to verify that the modification had the desired effect and no unintended adverse effects.
Bench Testing	Used to verify that the modification had the desired effect and no unintended adverse effects.
Canine Bone Healing Study	Used to verify that the modification had the desired effect and no unintended adverse effects.
Osteoinductivity Potential (DBM)	Each lot of DBM incorporates tested via: - In vitro surrogate cell-based assay: Measures proliferation of Saos human osteosarcoma cells (osteoiniductivity index), correlated to athymic rat model and clinical results of DBM alone. - In vitro immunoassay: Assays for native protein (BMP-2), correlated to athymic rat model for DBM alone and ALLOMATRIX® Putty. Note: The combination of DBM, CBM, and binding medium has not been evaluated for osteoinductivity, and correlation with human clinical performance is unknown.
Viral Inactivation Validation	Processing method for DBM evaluated for viral inactivation potential using a panel of model human viruses. Results: Demonstrated suitable viral inactivation potential for a wide spectrum of potential human viruses.

Non-Applicable Sections and Explanations:

The following sections are not applicable to this 510(k) summary because the device is a bone void filler, not an AI-powered diagnostic tool, and the submission is focused on demonstrating substantial equivalence for a component modification:

Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context would refer to the data used to evaluate AI performance. Here, testing involved a literature search, bench testing, and a canine study. Specific sample sizes for bench testing and the canine study are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a test set requiring expert ground truth in the context of diagnostic device validation. The "ground truth" for the osteoinductivity bioassay refers to correlation with athymic rat models and clinical results of DBM alone, not expert consensus on medical images or patient outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No such adjudication method is relevant to the type of testing described (bench, canine, in vitro assays).
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 is not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the osteoinductivity potential, the "ground truth" for the DBM bioassay/immunoassay was correlated with results from an athymic rat model and, in one instance, with clinical results of DBM alone. This is not "expert consensus" or "pathology" in the typical diagnostic sense. For viral inactivation, the "ground truth" would be the demonstrated inactivation of specific model viruses.
The sample size for the training set: Not applicable. There is no AI algorithm being trained.
How the ground truth for the training set was established: Not applicable. There is no AI algorithm being trained.

Summary

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K061939

JUL 1 8 2006

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SPECIAL 510(k): MODIFICATION TO COMPONENT

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of ALLOMATRIX® Custom Putty.

Submitted By:	Wright Medical Technology, Inc.
Date:	July, 7 2006
Contact Person:	Brian J. YoungSr. Director, Regulatory Affairs
Proprietary Name:	ALLOMATRIX® Custom Putty
Common Name:	Bone Void Filler
Classification Name and Reference:	Filler, Calcium Sulfate Preformed PelletsClass II, 888.3045
Device Product Code and Panel Code:	Orthopedics/MQV

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

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ز SUBSTANTIAL EQUIVALENCE INFORMATION

The modified ALLOMATRIX® Custom Putty was found to be substantially equivalent to the predicate device(s). A literature search, bench testing, and a canine bone healing study were used to verify that the modification had the desired effect and no unintended adverse effects.

Osteoinductivity Potential

ALLOMATRIX® Custom Bone Void Filler is a combination of Human Demineralized Bone Matrix (DBM) and cancellous bone matrix/chips (CBM) with a binding medium of calcium sulfate and carboxymethylcellulose.

Each lot of Demineralized Bone Matrix (DBM) incorporated into ALLOMATRIX® Custom is evaluated in vitro using a surrogate cell-based assay . The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from this bioassay were correlated to the athymic rat model2 and to clinical results of assayed DBM alone .

Each lot of DBM incorporated into ALLOMATRIX® Custom is assayed in vitro for a native protein (BMP-2) as a surrogate test marker for osteoinductive potential2. Results from this immunoassay were correlated to the athymic rat model for the DBM alone and the ALLOMATRIX® Putty . Although only one native protein is used as the test marker, it is the combination of various proteins that is responsible for its osteoinductive potential.

Testing each lot of DBM with this cell-based bioassay or immunoassay assures that only DBM with osteoinductive potential is used in the ALLOMATRIX® Custom. The combination of DBM, Cancellous Bone Matrix (CBM), and binding medium has not been evaluated for osteoinductivity; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via the in vitro bioassay or immunoassay, will correlate with human clinical performance of ALLOMATRIX® Custom.

Viral Inactivation Validation

The method for processing the DBM contained in ALLOMATRIX® Custom was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses.

Wilkins, R.M. (1999) Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Ccll Culture -Advances in Tissue Banking. 3:113-124.
This study correlated the results from the in viro bioassay to results in the athymic rat model and clinical results of the DBM.
1. Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300.
1. Data on file at Wright Medical Technology, Inc

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle symbol with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2006

Wright Medical Technology, Inc. % Mr. Brian J. Young Senior Director, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K061939

Trade/Device Name: ALLOMATRIX® Custom 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, MBP Dated: July 6, 2006 Received: July 10, 2006

Dear Mr. Young:

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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Mr. Brian J. Young

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Barbara Buckland

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known):_K06 1939

Device Name: ALLOMATRIX® Custom Bone Void Filler

Indications for Use:

ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. ALLOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Prescription Use _ X (Per21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Boubare Beehmp for mxu

Division of General, Restorative, and Neurological Devices

510(k) Number K061930

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.