(90 days)
Not Found
No
The summary describes a bone graft substitute material and its physical properties and performance in animal studies. There is no mention of AI or ML technology.
Yes
The device is indicated for filling bone voids or defects, provides an osteoconductive bone graft substitute, and supports bone fragments during surgical procedures, all of which are therapeutic actions aimed at treating a medical condition.
No
This device is a bone graft substitute material used for filling bone voids or defects. It is not used to diagnose conditions or diseases.
No
The device description clearly states it is a physical bone graft substitute material provided as a dry powder and an aqueous solution, requiring mixing and implantation. It is a physical medical device, not software.
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 Tactoset is a bone graft substitute material for filling bone voids or defects in the skeletal system. It is implanted directly into the body to aid in bone healing.
- Device Description: The description details the composition of the material itself, which is a calcium phosphate-based paste that hardens in the body.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
- Performance Studies: The performance studies focus on the material's physical properties, mechanical strength, and its ability to promote bone formation in an animal model. These are typical evaluations for an implantable medical device, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. Tactoset is an in vivo (inside the body) device used for surgical repair.
N/A
Intended Use / 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 device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new ling process and may be combined with autogenous bone marrow. 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.
Product codes (comma separated list FDA assigned to the subject device)
MOV, MQV
Device Description
Tactoset is an injectable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) 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 [CaHgO7], hyaluronic acid (HA), and water for injection. At a specified volume, the aqueous setting solution can be combined with autogenous bone marrow, i.e., bone marrow aspirate. Tactoset is provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Extremities and 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)
Bench testing data including analytical characterization, chemical composition, physical properties, mechanical testing (Pull-Out, Compressive Strength, Bone Alignment) and animal functional study were conducted for the subject Tactoset and the predicate devices. The results of the study demonstrate substantial equivalence to the predicate devices.
The performance of Tactoset + BMA was compared to Tactoset in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 14.90% in the Tactoset + BMA group, 14.65% in the Tactoset predicate group, and 5% in the empty defect negative control group. Animal study data demonstrated that approximately 54.3% of implant material remained in the Tactoset + BMA group and 60.9% remained in the Tactoset group 12 weeks following implantation. Clinical performance has not been evaluated.
No clinical data were required to support the substantial equivalence.
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.
Tactoset (K212083), Tactoset (K173008), MasterGraft Putty (K051386), MagnetOs Granules (K213111)
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
§ 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.
0
March 29, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Anika Therapeutics. Inc. % Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA Associate Director, Regulatory Affairs Mcra LLC. 803 7th Street NW Floor 3 Washington, District of Columbia 20001
Re: K223915
Trade/Device Name: Tactoset Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV Dated: December 29, 2022 Received: December 29, 2022
Dear Dr. Kazemzadeh-Narbat:
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
1
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 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,
Sara S. Thompson -S
For
Laurence D. Coyne, Ph.D. 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) K223915
Device Name Tactoset
Indications for Use (Describe)
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 device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new ling process and may be combined with autogenous bone marrow. 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.
X 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 |
|---|---|
| Manufacturer: | Anika Therapeutics, Inc. |
| 32 Wiggins Avenue | |
| Bedford, MA 01730 | |
| Contact: | Wei Zhao |
| Executive Director, Regulatory Affairs | |
| Mobile: (978)888-5948 | |
| E-Mail: wzhao@anika.com | |
| Prepared by: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA |
| Director, Regulatory Affairs, | |
| MCRA, LLC | |
| 803 7th Street NW, Floor 3 | |
| Washington, DC 20001 | |
| Office: 202.552.6011 | |
| mkazemzadeh@mcra.com | |
| Date Prepared: | Mar 23, 2023 |
| Classifications: | 21 CFR §880.3045, Resorbable calcium salt bone void filler device |
| Class: | II |
| Product Codes: | MQV |
| Primary Predicate: | Tactoset (K212083) |
| Additional Predicates: | Tactoset (K173008) |
| MasterGraft Putty (K051386) | |
| MagnetOs Granules (K213111) |
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 and may be combined with autogenous bone marrow. 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.
4
Device Description:
Tactoset is an injectable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) 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 [CaHgO7], hyaluronic acid (HA), and water for injection. At a specified volume, the aqueous setting solution can be combined with autogenous bone marrow, i.e., bone marrow aspirate. Tactoset is provided sterile for single use.
Predicate Device:
Anika Therapeutics, Inc. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices. Tactoset 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: | Tactoset (K212083) |
|---|---|
| Additional Predicates: | Tactoset (K173008) |
| MasterGraft Putty (K051386) | |
| MagnetOs Granules (K213111) |
Performance Testing Summary:
Bench testing data including analytical characterization, chemical composition, physical properties, mechanical testing (Pull-Out, Compressive Strength, Bone Alignment) and animal functional study were conducted for the subject Tactoset and the predicate devices. The results of the study demonstrate substantial equivalence to the predicate devices.
Substantial Equivalence:
The subject device is substantially equivalent to the Tactoset (K212083) 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, the same product classification and product code (MQV) and have similar "Indications for Use" statements in the extremities and pelvis. 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 and the primary predicate incorporate the same basic design, incorporates similar materials, have identical manufacturing process, identical packaging and are both provided sterile for single-patient, single-use in the same device volume.
The performance of Tactoset + BMA was compared to Tactoset in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 14.90% in the Tactoset + BMA group, 14.65% in the Tactoset predicate group, and 5% in the empty defect negative control group. Animal study data demonstrated that
5
approximately 54.3% of implant material remained in the Tactoset + BMA group and 60.9% remained in the Tactoset group 12 weeks following implantation. Clinical performance has not been evaluated.
No clinical data were required to support the substantial equivalence.
| Table 1. Substantial Equivalence of the Subject and Predicate Devices. | |||
|---|---|---|---|
| Information | Subject Device | Primary Predicate | |
| (Tactoset with Bone Marrow Aspirate) | |||
| Manufacturer | Anika Therapeutics, Inc. | Anika Therapeutics, Inc. | |
| Trade Name | Tactoset | Tactoset | |
| 510(k) Number | TBD | K212083 | |
| Product Code | MQV | MQV | |
| Classification | Resorbable calcium salt bone void filler device | Resorbable calcium salt bone void filler device | |
| Materials | Powder: 4g | Powder: 4g | |
| - α-Tricalcium phosphate | - α-Tricalcium phosphate | ||
| - Calcium carbonate | - Calcium carbonate | ||
| - Monocalcium phosphate | - Monocalcium phosphate | ||
| Liquid: 4mL setting solution, as supplied | Liquid: 4mL setting solution | ||
| - Sodium hyaluronate | - Sodium hyaluronate | ||
| - Citric acid | - Citric acid | ||
| - Sodium phosphate dibasic | - Sodium phosphate dibasic | ||
| 3mL of the supplied setting solution may be | |||
| combined with 1 mL of autogenous bone marrow | |||
| Physical Form | Injectable Paste/Putty | Injectable Paste/Putty | |
| Dimension (CC) | 4 | 4 | |
| Mixing Time (Min) | 1 | 1 | |
| Min Working Time | 7-18 | 7-18 | |
| (Min) | |||
| Setting Time (Min) | 10 | 10 | |
| Sterility Method | Single Use, Sterile, SAL 10-6 | Single Use, Sterile, SAL 10-6 | |
| Setting Solution: Autoclave and VHP | Setting Solution: Autoclave and VHP | ||
| Powder Component: Gamma Irradiation | Powder Component: Gamma Irradiation | ||
| Pyrogenicity | LAL |