(81 days)
No
The summary describes a mechanical implant system and its instrumentation, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is intended for fracture fixation and joint arthrodesis, which are therapeutic interventions aimed at treating medical conditions.
No
The device is described as an implant system for fracture fixation and joint arthrodesis, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it consists of "implants and related instrumentation for implantation," which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fracture fixation, and joint arthrodesis of the foot and ankle." This describes a surgical procedure performed directly on the patient's body to stabilize bones or fuse joints.
- Device Description: The device consists of "implants and related instrumentation for implantation." These are physical devices designed to be surgically placed within the body.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of bodily specimens.
Therefore, based on the provided information, the Treace Medical Concepts (TMC) Compression Implant System is a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Treace Medical Concepts (TMC) Compression Implant System consists of implants and related instrumentation for implantation. The implant is offered in multiple combinations of bridge lengths, leg lengths, cross sections and cannulated versions to accommodate various anatomies. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The subject device was compared to the primary predicate device. Z-Staples, per ASTM F564 for Bone Metallic Staples. The testing demonstrated that the subject device met all acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate device.
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.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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February 8, 2023
Treace Medical Concepts Brittany Grochala Sr. Regulatory Affairs Specialist 203 Fort Wade Road, Suite 150 Ponte Vedra, Florida 32081
Re: K222645
Trade/Device Name: Treace Medical Concepts (TMC) Compression Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR
Dear Brittany Grochala:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 21, 2022. Specifically, FDA is updating this SE Letter as an administrative correction to the Trade/Device Name from "Treace Medical Concepts (TMC) Implant Fixation System" to "Treace Medical Concepts (TMC) Compression Implant System".
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, Ph.D., OHT6: Office of Orthopedic Devices, 301-796-7056, Limin.Sun(@fda.hhs.gov.
Sincerely,
Image /page/0/Picture/9 description: The image shows the text "Limin Sun -S" in a large, sans-serif font. The text is black and the background is white. The words are arranged horizontally, with "Limin" and "Sun" being the most prominent words. The "-S" is smaller and slightly offset to the right.
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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November 21, 2022
Treace Medical Concepts Brittany Grochala Sr. Regulatory Affairs Specialist 203 Fort Wade Road, Suite 150 Ponte Vedra, Florida 32081
Re: K222645
Trade/Device Name: Treace Medical Concepts (TMC) Implant Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: August 31, 2022 Received: September 1, 2022
Dear Brittany Grochala:
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.
2
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); 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 medical devices and radiation-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.
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222645
Device Name
Treace Medical Concepts (TMC) Compression Implant System
Indications for Use (Describe)
The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image is a logo for Treace Medical Concepts, Inc. The logo features the word "TREACE" in gray, with a red swoosh above the "A". Below the word "TREACE" is the text "Medical Concepts, Inc." in gray. Below that is the text "The Leader in Hallux Valgus Surgery" in red.
510(k) Summary Treace Medical Concepts (TMC) Compression Implant System August 31st, 2022
| Company: | Treace Medical Concepts, Inc.
203 Fort Wade Road, Suite 150
Ponte Vedra, FL 32081 |
|-----------------------------|-----------------------------------------------------------------------------------------|
| Establishment Registration: | 3011623994 |
| Primary Contact: | Brittany Grochala, Sr. Regulatory Affairs Specialist |
| | Phone: 515-865-0494 |
| | Fax: 904-834-7169 |
| | Email: bgrochala@treace.net |
| Secondary Contact: | Kristina Hall, Director, Regulatory Affairs |
| | Phone: 904-373-5940 ext. 1321 |
| | Fax: 904-834-7169 |
| | Email: khall@treace.net |
| Trade Name: | Treace Medical Concepts (TMC) Compression Implant |
| | System |
| Common Name: | Staple, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 Single/multiple component metallic bone |
| | fixation appliances and accessories. |
| Panel: | 87- Orthopedic |
| Product Code(s): | JDR Staple, Fixation, Bone |
Predicate Device(s):
Primary Predicate:
-
Z-Medical Z-Staple (K121277, S.E. 11/07/2012) .
Additional Predicate: -
Wright Medical FuseForce™ Flex Dynamic Compression System (K203832, S.E. . 05/07/2021)
Reference Device: -
Treace Medical Concepts (TMC) Plating System (K220136, S.E. 02/16/2022) .
Device Description:
The Treace Medical Concepts (TMC) Compression Implant System consists of implants and related instrumentation for implantation. The implant is offered in multiple combinations of bridge lengths, leg lengths, cross sections and cannulated versions to accommodate various anatomies. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.
5
Image /page/5/Picture/0 description: The image shows the logo for TREACE Medical Concepts, Inc. The logo is in gray, except for a red swoosh above the letter A. Below the company name is the tagline "The Leader in Hallux Valgus Surgery" in red.
The purpose of this traditional 510(k) submission is for the introduction of the Treace Medical Concepts (TMC) Compression Implant System.
All implantable components are manufactured from implant grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
Indications for Use:
The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.
Substantial Equivalence:
The subject TMC Compression Implant System is substantially equivalent to the following predicate and reference devices:
Primary Predicate:
-
Z-Medical Z-Staple (K121277, S.E. 11/07/2012) .
Additional Predicate: -
Wright Medical FuseForce™ Flex Dynamic Compression System (K203832, S.E. . 05/07/2021)
Reference Device: -
Treace Medical Concepts (TMC) Plating System (K220136, S.E. 02/16/2022) .
The subject compression implants are intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle, equivalent to the predicate devices. The subject compression implants are manufactured from implant grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and also share similar materials, geometry, construction, packaging, and overall design with the predicate and reference devices (Z-Staple and TMC Plating System). Thus, it can be concluded that the subject devices do not raise new questions about safety and effectiveness and are substantially equivalent to the predicate and reference devices.
Performance Testing:
The subject device was compared to the primary predicate device. Z-Staples, per ASTM F564 for Bone Metallic Staples. The testing demonstrated that the subject device met all acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate device.
Conclusion:
The TMC Compression Implant System has similar intended use, overall design, materials, and mechanical properties to that of the predicate and reference devices. Therefore, it can be concluded that the subject device is at least as safe and substantially equivalent to the predicate and reference devices.