(30 days)
Not Found
No
The 510(k) summary describes a mechanical screw fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for use in fracture repair, revision procedures, joint fusions, bone reconstructions, osteotomy, and ligament fixation, which are all therapeutic interventions for medical conditions.
No
The Treace Medical Concepts (TMC) Screw Fixation System is described as a system of screws intended for surgical fixation of bones (e.g., fracture repair, fusions, osteotomy), which are therapeutic and reconstructive uses, not diagnostic.
No
The device description explicitly states that the system includes "headed and headless cannulated screws" and "implantable components are manufactured from medical grade titanium alloy". This indicates a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device description: The description clearly states that the Treace Medical Concepts (TMC) Screw Fixation System is a system of screws intended for fixation of bones in surgical procedures. These are implantable devices used directly on the patient's anatomy.
- Intended Use/Indications for Use: The intended use describes surgical procedures involving bone fixation, not the analysis of biological specimens.
Therefore, the device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- · mono or bicortical osteotomies
- · distal or proximal metatarsal osteotomies
- · weil osteotomy
- · fusion of the metatarsalphalangeal joint
- · fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- · talonavicular fusions
- cuboid fusions
Not for spinal use.
Product codes
HWC
Device Description
Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.
The purpose of this special 510(k) submission is to add a new non-cannulated screw option known as the Rapid Insertion Implant System.
All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small or long bones, scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid. In the foot: mono or bicortical osteotomies, distal or proximal metatarsal osteotomies, weil osteotomy, fusion of the metatarsalphalangeal joint, fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.), Akin type osteotomy, talonavicular fusions, cuboid fusions. Not for spinal use.
Indicated Patient Age Range
adult and pediatric patients aged >12 years
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)
Performance Testing:
The following performance testing has been completed in accordance with ASTM F543:
- Torque To Failure and Insertion & Removal Torque
- . Axial Pullout - Driver Disengagement
- Axial Pullout - Bone Screw Disengagement
Testing demonstrated that the subject screws met all acceptance criteria and can be considered substantially equivalent to the predicate screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K172617 TMC Compression Screw System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
October 21, 2021
Treace Medical Concepts, Inc. % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial. Colorado 80112
Re: K213036
Trade/Device Name: Treace Medical Concepts (TMC) Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 20, 2021 Received: September 21, 2021
Dear Danielle Besal:
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.
1
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.
Shumaya Ali, MPH 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) K213036
Device Name
Treace Medical Concepts (TMC) Screw Fixation System
Indications for Use (Describe)
The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- · mono or bicortical osteotomies
- · distal or proximal metatarsal osteotomies
- · weil osteotomy
- · fusion of the metatarsalphalangeal joint
- · fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- · talonavicular fusions
- cuboid fusions
Not for spinal use.
| 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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3
| 510(k) Summary | |
|---|---|
| Treace Medical Concepts (TMC) Screw Fixation System | |
| October 21, 2021 | |
| Company: | Treace Medical Concepts, Inc. |
| 203 Fort Wade Rd., Suite 150 | |
| Ponte Vedra, FL 32081 | |
| Primary Contact: | Danielle Besal |
| Principal Consultant, MRC Global | |
| Phone: 901-827-8670 | |
| Danielle.Besal@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) Screw Fixation System |
| Common Name: | Screw, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener) |
| Panel: | 87- Orthopedic |
| Product Code: | HWC |
| Primary Predicate: | K172617 TMC Compression Screw System |
Device Description:
Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.
The purpose of this special 510(k) submission is to add a new non-cannulated screw option known as the Rapid Insertion Implant System.
All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
4
K213036
Indications for Use:
The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- . mono or bicortical osteotomies
- distal or proximal metatarsal osteotomies
- . weil osteotomy
- fusion of the metatarsalphalangeal joint
- fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- talonavicular fusions
- . cuboid fusions
Not for spinal use.
Substantial Equivalence:
The subject TMC Screw Fixation System is substantially equivalent to the predicate Treace Medical Concepts (TMC) Compression Screw System (K172617).
The subject screws are manufactured from titanium (Ti-6Al-4V-ELI) and are 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 slightly modified to very clearly state the age range of the patient population. The patient population has not changed. The subject screws also share similar geometry and construction with the predicate.
Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
The following performance testing has been completed in accordance with ASTM F543:
- Torque To Failure and Insertion & Removal Torque
- . Axial Pullout - Driver Disengagement
- Axial Pullout - Bone Screw Disengagement
Testing demonstrated that the subject screws met all acceptance criteria and can be considered substantially equivalent to the predicate screws.
5
K213036
Conclusion:
The Treace Medical Concepts (TMC) Screw Fixation System has identical intended use, similarities in design and construction, and equivalent performance to the predicate device as demonstrated through bench testing and engineering analysis. Therefore, it can be concluded that the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device.