Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Device Description

Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), and water for injection. Tactoset® Injectable Bone Substitute is provided sterile for single use in volumes ranging from 1cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called Tactoset Injectable Bone Substitute. It aims to demonstrate that this new device is "substantially equivalent" to legally marketed predicate devices, meaning it is as safe and effective.

The provided document does not contain the detailed information necessary to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. This 510(k) is for a bone substitute material, not an AI or imaging device. The performance testing summary explicitly states:

"Non-clinical verification testing data submitted to demonstrate substantial equivalence included bench performance testing as follows: Pull-out testing, Bone alignment testing"
"Pyrogenicity and bacterial endotoxin testing were performed..."
"No animal performance testing or clinical data are included in this submission."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these are concepts primarily applicable to the validation of AI/ML or diagnostic imaging devices, not a bone void filler.

The document does not describe the following:

A table of acceptance criteria and the reported device performance (in the context of an AI/ML study).
Sample sizes used for a test set (related to AI/ML).
Number of experts used to establish ground truth for a test set.
Adjudication method for a test set.
Multi reader multi case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How the ground truth for the training set was established.

Summary

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August 31, 2021

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Anika Therapeutics. Inc. % Wei Zhao Director, Regulatory Affairs Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730

Re: K212083

Trade/Device Name: Tactoset® Injectable Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: July 2, 2021 Received: July 2, 2021

Dear Wei Zhao:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212083

Device Name Tactoset Injectable Bone Substitute

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Device Trade Name:	Tactoset® Injectable Bone Substitute
Manufacturer:	Anika Therapeutics, Inc.32 Wiggins AvenueBedford, MA 01730
Contact:	Wei ZhaoDirector, Regulatory AffairsMobile: (978)888-5948E-Mail: wzhao@anika.com
Prepared by:	Mehdi Kazemzadeh-Narbat, PhD, PMP, CQAAssociate Director, Regulatory Affairs,MCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: 202.552.6011mkazemzadeh@mcra.com
Date Prepared:	August 19, 2021
Classifications:	21 CFR §880.3045, Resorbable calcium salt bone void filler device
Class:	II
Product Codes:	MQV
Primary Predicate:	SCS 17-01 (K173008)
Additional Predicates:	SCS 17-01 (K190956)Cerament Bone Void Filler (K201535)PRO DENSE (K182823)

Indications For Use:

Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

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Device Description:

Predicate Device:

Anika Therapeutics, Inc. submits the following in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Tactoset® Injectable Bone Substitute is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:

Primary Predicate:	SCS 17-01 (K173008)
Additional Predicates:	SCS 17-01 (K190956)Cerament Bone Void Filler (K201535)PRO-DENSE (K182823)

Performance Testing Summary:

Non-clinical verification testing data submitted to demonstrate substantial equivalence included bench performance testing as follows:

Pull-out testing
Bone alignment testing

Pyrogenicity and bacterial endotoxin testing were performed using methods described in USP 39-NF 34 <151> and USP 39-NF 34 <85>, and results were below the limits set by the acceptance criteria.

Substantial Equivalence:

The subject device is identical to the SCS 17-01 in terms of material composition, manufacturing process, sterilization and packaging and both are manufactured in the same facility.

The subject device and the predicate devices (primary and additional) have the same intended uses, same product cclassification and product coode (MQV) and have the similar "Indications for Use" statements. The subject device and the predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure. The subject device, primary predicate device, and additional predicate device all have indications for use in the extremities and pelvis. The subject device and the predicate devices are provided sterile for single-patient, single-use in similar ranges of graft volumes.

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No animal performance testing or clinical data are included in this submission.

Overall, Tactoset® Injectable Bone Substitute has the following similarities to the predicate devices:

has the same intended use,
uses the same operating principle,
incorporates the same basic design,
incorporates identical materials,
has identical manufacturing process, ●
has identical packaging and is sterilized using the same materials and processes. ●

Conclusion:

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Tactoset® Injectable Bone Substitute is as safe, as effective, and performs as well as, or better, than the predicate devices.

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.