CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON

• K Number: K072327
• Device Name: CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
• Manufacturer: REGENERATION TECHNOLOGIES, INC.
• Date Cleared: 2007-10-24 ( 65 days)
• Product Code: MQV ORT
• Regulation Number: 888.3045

Intended Use

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Device Description

The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bone void filler made from processed bovine bone. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

Therapeutic

Yes.
The device is a void filler that remodels into the recipient's skeletal system, meaning it directly treats or palliates a condition (bony voids or gaps) within the body.

Diagnostic

No

This device is described as a "void filler that remodels into the recipient's skeletal system" for bony voids or gaps. Its function is to fill and integrate with bone, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product ("machined into a wedge shape from bovine bone").

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Description and Intended Use: The description clearly states that this device is a bone void filler made from bovine bone, intended to be placed directly into bony voids or gaps in the skeletal system. This is a surgical implant, not a test performed on a sample outside the body.

The device's function is to physically fill a void and remodel into the bone, which is a therapeutic intervention, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

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

MQV

Device Description

The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skeletal system (e.g., extremities, spine, ilium and/or pelvis)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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.

Not Found

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

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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a black square on the left, followed by the word "Regeneration" in a bold, sans-serif font. Below the word "Regeneration" is the phrase "TECHNOLOGIES, INC." in a smaller, sans-serif font. The letters are all capitalized.

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

K072327

Tel [phone] Toll Free 877.343.6832 Fax [phone] www.rtix.com

Attachment 4: 510(K) Summary

August 17, 2007

Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: [phone] x4326 Fax: [phone] Proprietary Name: CANCELLO-PURE™ Wedge

Common Name: Filler, bone void, calcium compound

Product Code: MQV, Orthopedics Panel

Code Section: 21 CFR 888.3045

Substantial Equivalence:

The CANCELLO-PURE™ Wedge is substantially equivalent to predicate devices in materials, design, and function.

Description:

The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.

Intended Use:

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Summary of Technological Characteristics:

The CANCELLO-PURE™ Wedge has materials, design and function equivalent to predicate devices. The source of bovine bone used in the manufacture of these products is a closed herd located in the U.S.A.

The BioCleanse® Tissue Sterilization Process, used in the manufacture of these products, has been shown to render processed bovine bone capable of remodeling comparably to

OCT 2 4 2007

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Image /page/1/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The word "Regeneration" is in large, bold, black letters with a trademark symbol in the upper right corner. Below that, in smaller letters, is the text "TECHNOLOGIES, INC."

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

Tel [phone] Toll Free 877.343.6832 Fax [phone] www.rtix.com

allograft in an animal model. A viral inactivation study using a worst-case representation of the BioCleanse® process has shown reduction of a panel of viruses to below detectable limits.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Regeneration Technologies, Inc. % Ms. Lisa Simpson 11621 Research Circle P. O. Box 2650 Alachua, FL 32616-2650

OCT 2 4 2007

Re: K072327

Trade/Device Name: Cancello-Pure™ Wedge Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: September 20, 2007 Received: September 24, 2007

Dear Ms. Simpson:

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 (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.

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Page 2 - Ms. Lisa Simpson

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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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Attachment 2: Indications for Use

510(k) Number (if known):

Device Name:

CANCELLO-PURE™ Wedge

Indications for Use:

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodel into the recipient's skeletal system.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PACE OF NEEDED)

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number