(28 days)
Not Found
No
The 510(k) summary describes a system of bone screws and instrumentation for fracture fixation and other orthopedic procedures. There is no mention of AI or ML in the intended use, device description, or performance studies. The modifications are related to additional screw options and minor internal documentation changes.
Yes
The device is a system of screws intended for the fixation of fractures, repair, fusions, and reconstruction of bones in adult and pediatric patients. These applications fall under the definition of therapeutic interventions.
No
The device description and intended use clearly state that the TMC Screw Fixation System is for fixation of bones, fracture repair, and other surgical procedures. It is an implantable device used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the system includes "headed and headless cannulated screws" manufactured from "implant grade titanium alloy," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The TMC Screw Fixation System is described as a system of headed and headless cannulated screws made from titanium alloy. These are physical implants used to fix bones.
- Intended Use: The intended use clearly states the system is for "fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones." This involves surgical procedures on the body, not laboratory testing of samples.
The device is a surgical implant used for orthopedic procedures, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
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.
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 (comma separated list FDA assigned to the subject device)
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, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.
All implantable components are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
The primary purpose of this Special 510(k) submission is to introduce additional screw options and accompanying instrumentation within the Treace Medical Concepts (TMC) Screw Fixation System. Secondly, Treace is providing the Agency notification regarding minor modifications implemented for the TMC Screw Fixation System via internal documentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small or long bones including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid. Specific examples in the foot are 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, and 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)
Mechanical testing and analysis per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws was performed on the subject screws to evaluate torsional strength, driving and removal torque, and axial pullout strength. The subject screws were assessed under the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020. The subject screws met all acceptance criteria and can be considered substantially equivalent to predicate screws.
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.
Treace Medical Concepts (TMC) Screw Fixation System (K213036. S.E. 10/21/2021)
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
§ 888.3040 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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 4, 2024
Treace Medical Concepts Inc. Melissa Coloroso Principal Regulatory Affairs Specialist 100 Palmetto Park Place Ponte Vedra, Florida 32081
Re: K242671
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 5, 2024 Received: September 6, 2024
Dear Melissa Coloroso:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
K242671 - Melissa Coloroso
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shumava A
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Treace Medical Concepts (TMC) Screw Fixation System
Indications for Use (Describe)
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 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 Valqus treatment
Prescription Use (Part 21 CFR 801 Subpart D)
(such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- · talonavicular fusions
- · cuboid fusions
Not for sninal use
Type of Use (Select one or both, as applicable)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Treace Medical Concepts, Inc. The logo consists of the word "TREACE" in gray, with a red swoosh above the "A". Below the word "TREACE" is the phrase "Medical Concepts, Inc." in gray. Below that is the phrase "A Step Ahead in Foot and Ankle Surgery" in red.
Page 1
510(k) Summary
Treace Medical Concepts (TMC) Medical Concepts Screw Fixation System September 05, 2024
| Company: | Treace Medical Concepts, Inc.
100 Palmetto Park Place
Ponte Vedra, FL 32081 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | 3011623994 |
| Primary Contact: | Melissa Coloroso, Principal Regulatory Affairs Specialist
Phone: 303-641-8592
Fax: 904-834-7169
Email: mcoloroso@treace.net |
| Secondary Contact: | Kristina Hall, Sr. Director, Regulatory Affairs
Phone: 904-373-5940 ext. 1321
Fax: 904-834-7169
Email: khall@treace.net |
| Trade Name: | Treace Medical Concepts (TMC) Plating 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(s): | HWC |
Predicate Device(s):
Primary Predicate: Treace Medical Concepts (TMC) Screw Fixation System (K213036. S.E. 10/21/2021)
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, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.
All implantable components are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
The primary purpose of this Special 510(k) submission is to introduce additional screw options and accompanying instrumentation within the Treace Medical Concepts (TMC) Screw Fixation System. Secondly, Treace is providing the Agency notification regarding minor modifications implemented for the TMC Screw Fixation System via internal documentation.
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Image /page/5/Picture/0 description: The image shows the logo for Treace Medical Concepts, Inc. The logo consists of 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 "A Step Ahead in Foot and Ankle Surgery" in red.
Page 2
The changes described within this submission do not impact reprocessing, sterility, and biocompatibility considerations in comparison to the predicate device. The software, cybersecurity, EMC, and wireless technology sections are not applicable to the subject device.
Indications for Use:
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, 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 TMC Screw Fixation System (K213036, S.E. 10/21/2021).
The subject screws are manufactured from implant grade titanium alloy (Ti6A14V-ELI) per ASTM F136 and 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.
The subject TMC Screw Fixation System shares identical materials and similar geometry, construction, and overall design with the predicate system. The technological differences between the subject and predicate devices include geometric modifications. Any differences in the technological characteristics of the subject device compared to the predicate device do not raise any new questions of safety and effectiveness. Thus, it can be concluded that the subject device is substantially equivalent to the predicate device.
Performance Testing:
Mechanical testing and analysis per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws was performed on the subject screws to evaluate torsional
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Image /page/6/Picture/0 description: The image shows the 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 "A Step Ahead in Foot and Ankle Surgery" in red.
Page 3
strength, driving and removal torque, and axial pullout strength. The subject screws were assessed under the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020. The subject screws met all acceptance criteria and can be considered substantially equivalent to predicate screws.
Conclusion:
The subject Treace Medical Concepts (TMC) Screw Fixation System has identical intended use, similar design, and equivalent performance to predicate devices as demonstrated through bench testing and engineering analysis. Therefore, it can be concluded that the subject device is as safe and effective and substantially equivalent to predicate devices.