← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K220136 # Treace Medical Concepts (TMC) Plating System (K220136) _Treace Medical Concepts, Inc. · HRS · Feb 16, 2022 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K220136 ## Device Facts - **Applicant:** Treace Medical Concepts, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Feb 16, 2022 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## Intended Use The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. The system can be used in both and pediatric patients aged > 12 years. In the foot, the system can be used for the following specific examples: - First metatarsal osteotomies for hallux valgus correction such as: - Opening base wedge osteotomy - · Closing base wedge osteotomy - · Crescentic osteotomy - · Proximal Chevron osteotomy - · Distal Chevron osteotomy (Austin) - First metatarsal fracture fixation - Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of - deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and / or arthritis - Flatfoot Osteotomies - · Lateral Column Lengthening (Evans Osteotomy) - · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton - Osteotomy) - Mid / Flatfoot Fusions - · LisFranc Arthrodesis and/or Stabilization - · Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - · Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion ## Device Story TMC Plating System consists of metallic plates (straight, L-shaped, H-shaped, curved, Python) and screws; used for bone fixation, fusion, and reconstruction of small foot bones. Operated by surgeons in clinical settings; provides mechanical stabilization of bone segments during healing. Benefits include structural support for osteotomies, fusions, and fracture repair. No electronic or software components. ## Clinical Evidence No clinical data; bench testing not required for this submission as it involves a clarification of the indications for use statement. ## Technological Characteristics Materials: Medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. Components: Plates (straight, L-shaped, H-shaped, curved, Python) and screws. Sterilization: Gamma irradiation. No software or electronic components. ## Regulatory 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. ## Predicate Devices - TMC Plating System ([K200961](/device/K200961.md)) - TMC Plating System ([K192504](/device/K192504.md)) - TMC Plating System ([K183321](/device/K183321.md)) - TMC Plating System ([K153531](/device/K153531.md)) - TMC Plating System ([K143717](/device/K143717.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ February 16, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Treace Medical Concepts, Inc. % Dawn Norman Partner MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial. Colorado 80112 Re: K220136 Trade/Device Name: Treace Medical Concepts (TMC) Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: January 14, 2022 Received: January 18, 2022 Dear Dawn Norman: 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}------------------------------------------------ gencies. You must comply with all the Act's Page 2 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, For: Shumaya Ali, M.P.H. 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 {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K220136 Device Name Treace Medical Concepts (TMC) Plating System Indications for Use (Describe) The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. The system can be used in both and pediatric patients aged > 12 years. In the foot, the system can be used for the following specific examples: - First metatarsal osteotomies for hallux valgus correction such as: - Opening base wedge osteotomy - · Closing base wedge osteotomy - · Crescentic osteotomy - · Proximal Chevron osteotomy - · Distal Chevron osteotomy (Austin) - First metatarsal fracture fixation - Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of - deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and / or arthritis - Flatfoot Osteotomies - · Lateral Column Lengthening (Evans Osteotomy) - · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton - Osteotomy) - Mid / Flatfoot Fusions - · LisFranc Arthrodesis and/or Stabilization - · Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - · Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary Treace Medical Concepts (TMC) Plating System February 15, 2022 | Company: | Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra, FL 32081 | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Dawn Norman
Partner, MRC Global
Phone: 618-604-3064
Dawn.Norman@askmrcglobal.com | | Company Contact: | Kristina Hall
Regulatory Affairs Director
Treace Medical Concepts, Inc.
Phone: 904.373.5940
khall@treace.net | | Trade Name: | Treace Medical Concepts (TMC) Plating System | | Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone | | Classification: | Class II | | Regulation Number: | 21 CFR 888.3030 (Single/multiple component metallic bone
fixation appliances and accessories) (primary)
21 CFR 888.3040 (Smooth or threaded metallic bone fixation
fastener) | | Panel: | 87- Orthopedic | | Product Code: | HRS; HWC | | Primary Predicate: | K200961 TMC Plating System | #### Device Description: The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, curved and Python plates and associated screws. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot. The purpose of this special 510(k) is to clarify the indications for use for the Treace Medical Concepts (TMC) Plating System (K192504 and K200961). All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation. {4}------------------------------------------------ ## Indications for Use: The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. The system can be used in both adult and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples: - First metatarsal osteotomies for hallux valgus correction such as: - · Opening base wedge osteotomy - Closing base wedge osteotomy - · Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) - Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and / or arthritis - First metatarsal fracture fixation - Flatfoot Osteotomies - · Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton - Osteotomy) - Mid / Flatfoot Fusions - LisFranc Arthrodesis and/or Stabilization - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion ## Substantial Equivalence: The subject TMC Plating System is substantially equivalent to the predicate TMC Plating System previously cleared in K143717, K153531, K183321, K192504, and K200961. The subject TMC Plating System is manufactured from titanium (Ti-6Al-4V-ELI) and is intended to be used in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet, identical to the predicate devices. Indications for use have been clarified and were found through a risk analysis including literature review to be equivalent to the predicate device. The subject TMC Plating System also shares similar geometry, and construction with the predicate devices. {5}------------------------------------------------ Thus, it can be concluded that the subject changes to the Indications for Use do not raise new questions about safety and effectiveness. ## Performance Testing: Performance testing was not required to support the clarification of the indications statement. ## Conclusion: The Treace Medical Concepts (TMC) Screw Fixation System has identical design and construction to the predicate devices. A risk analysis found that the Indications for Use statement remain substantially equivalent to those of the system in previous clearances. Therefore, it can be concluded that the subject device is as safe, as effective, and performs as safely and effectively as the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K220136](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K220136) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com