Predicate Devices

K050806, K043421, K051195, K050642, K040262

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a bone graft material and its components, with no mention of AI or ML technology.

Therapeutic

Yes
This device is a bone graft extender and bone void filler, which indicates it's used to treat skeletal defects, thus serving a therapeutic purpose.

Diagnostic

No.
The device is described as a bone graft extender and bone void filler, used to replace bone during healing. Its function is therapeutic/reconstructive rather than diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a kit containing physical components like polymer powder, bone chips, mixing solution, and tools, which are 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 clearly states that OpteCure + CCC is a bone graft extender and bone void filler for surgical or traumatic osseous defects. This is a therapeutic and structural application, not a diagnostic one.
Device Description: The description details the components of the kit (polymer powder, bone chips, DBM, mixing solution) and how it forms a putty for placement in bone voids. This aligns with a material used for repair or regeneration, not for testing samples outside the body.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
Performance Studies: The performance studies focus on osteoinductivity (the ability to stimulate bone growth) and viral inactivation, which are relevant to the safety and efficacy of a bone graft material, not a diagnostic test.

In vitro diagnostics (IVDs) are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. OpteCure + CCC does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Optecure™ + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Optecure™ + CCC may be used with rigid fixation systems.

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

MQV, MBP

Device Description

Optecure™ + CCC is packaged in the form of a kit with pre-measured polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), premeasured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids. Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Extremities, spine, 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)

a. Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in-vivo athymic mouse assay. Findings from the animal model are not necessarily predictive of human clinical results.

b. A viral reduction study was conducted by a CLIA certified testing laboratory using four virus models representing RNA, DNA, envelope and non-envelope virus. This study demonstrates the demineralization process used on donor bone contained in Optecure™ + CCC significantly diminishes these model viruses and can reasonably be anticipated to diminish the titers of other viruses.

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.

K050806, K043421, K051195, K050642, K040262

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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2320 NW 66TH COURT GAINESVILLE, FL 32653

Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

House stransmission in the

SEP 1 2 2006

352-377-1140 FAX 352-378-2617

Traditional 510(k) Summary of Safety and Effectiveness

This 510(k) Summary for Optecure™ + CCC is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

| Sponsor: | Exactech Inc.
2320 NW 66th Court
Gainesville, Florida 32653
Telephone 352-377-1140
Fax 352-378-2617 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FDA Establishment Number 1038671 |
| Contact: | Maritza Elias
Regulatory Representative
Exactech Inc.
2320 NW 66th Court
Gainesville, Florida
Telephone 352-377-1140
Fax 352-378-2617 |
| Proprietary Name: | Optecure™ + CCC |
| Common Name: | Bone void filler, |
| Product Code: | MQV, MBP |
| Device Class: | Class II |
| Classification Name: | 21CFR §888.3045 Resorbable calcium salt
bone void filler device |
| Classification Panel: | Orthopedic |

Rev 06 07 06

Section 4 Page 1 of 3

A Great Day in the O.R.

EXACIECH assist to inqrowe the quality of the notin'n their octin'y ond independent. We do this through including poducts, aduction and consimation to series

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2320 NW 66TH COURT GAINESVILLE, FL 32653

Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

352-377-1140 FAX 352-378-2617

Traditional 510(k) Summary of Safety and Effectiveness

Legally Marketed Devices for Substantial Equivalence Comparison:

| Product

Code	Manufacturer	510(k) Number	Product
MQV, MBP	Exactech Inc.	K050806	Optecure™
MQV	Regeneration
Technologies	K043421	Opteform®
MQV, MBP	Osteotech	K051195	Grafton® DBM
MQV, MBP	IsoTis	K050642	OrthoBlast® II
MQV, MBP	Muskuloskeletal
Tissue
Foundation	K040262	DBX® Demineralized Bone
Matrix Mix

Optecure™ + CCC is substantially equivalent to one or more of the 510(k) cleared predicate devices summarized in the above table in that they share similar design, material composition and function.

Device Description:

Optecure™ + CCC is packaged in the form of a kit with pre-measured polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), premeasured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids.

Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.

Indications:

Optecure™ + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Optecure™ + CCC may be used with rigid fixation systems.

Rev 06 07 06

Section 4 Page 2 of 3

A Great Day in the O.R.

EXACTECH exist to intraduals by maintining their a citivity and independere. We do this through increative iseas, high-quoting products, education and commitment to sence

2

Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX 352-378-2617

Traditional 510(k) Summary of Safety and Effectiveness

Safety & Effectiveness Information

Ostcoinductive Potential a.

Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in-vivo athymic mouse assay. Findings from the animal model are not necessarily predictive of human clinical results.

b. Viral Inactivation Validation

A viral reduction study was conducted by a CLIA certified testing laboratory using four virus models representing RNA, DNA, envelope and non-envelope virus. This study demonstrates the demineralization process used on donor bone contained in Optecure™ + CCC significantly diminishes these model viruses and can reasonably be anticipated to diminish the titers of other viruses.

Rev 06 07 06

Section 4 Page 3 of 3

A Great Day in the O.R."

EXACTECH exist to inprove the quality of it in independent. We to the more interest increative increative idess, high-quility podect, aduction and commitment senses.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2006

Exactech % Ms. Maritza Elias Regulatory Representative 2320 NW 66th Court Gainesville, FL 32653

Re: K061668

Trade/Device Name: Optecure™ +CCC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Codes: MBP, MQV Dated: June 7, 2006 Received: June 14, 2006

Dear Ms. Elias:

:

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 l'ederal 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);

4

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 m 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), n you deente spee 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 may bound band gallery, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address .

Sincerely yours,

Barbaya Buckins

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

Enclosure

5

Exactech, Inc.® Optecure™ + CCC Traditional 510(k)

Indications For Use

510(k) Number (if known):

Indications for Use:

OpteCure + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Thesper of ent may be surgically created osseous defects or osseous defects created from to autonatic injury to the bone.

OpteCure may be used with rigid fixation systems.

Prescription Use

Over the Counter Use VANJAO.

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

Rev 05/30/06

510(k) Number K061668

Section 3 Page 1 of 1