← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K183363 # Treace Medical Concepts (TMC) Snap-Off Screw System (K183363) _Treace Medical Concepts, Inc. · HWC · Jun 13, 2019 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K183363 ## Device Facts - **Applicant:** Treace Medical Concepts, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jun 13, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## Intended Use The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as 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, 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 - fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - Akin type osteotomy Not for spinal use. ## Device Story The TMC Snap-Off Screw System consists of self-drilling and self-tapping titanium alloy screws (2.0mm and 2.7mm diameters). Used by surgeons in clinical settings for bone fixation, fracture repair, and osteotomies. The device functions as a mechanical fastener to stabilize bone segments. The 'snap-off' design allows for precise length adjustment during implantation. The system provides mechanical stability to facilitate bone healing and reconstruction. No software or electronic components are involved. ## Clinical Evidence Bench testing only. Performance testing evaluated torsion and pull-out properties in accordance with ASTM F543 to demonstrate substantial equivalence to the predicate device. ## Technological Characteristics Materials: Titanium alloy (ASTM F136). Finish: Type III Titanium Color Anodization. Design: Self-drilling and self-tapping screws, 2.0mm and 2.7mm diameters. Mechanical fixation principle. No software, energy source, or connectivity. ## Regulatory 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. ## Predicate Devices - Integra SPIN Snap-Off Screw ([K991477](/device/K991477.md)) - TMC Compression Screw System ([K172617](/device/K172617.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 25, 2021 Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President MRC-X. LLC 6075 Poplar Avenue Suite 500 Memphis, Tennessee 38119 Re: K183363 Trade/Device Name: Treace Medical Concepts (TMC) Snap-Off Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dear Dawn Norman: 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 June 13, 2019. Specifically, FDA is updating this SE Letter to correct a typo in the trade name identified on the previous SE Letter as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, MPH, OHT6: Office of Orthopedic Devices, (301)796-2356, Shumaya.Ali@fda.hhs.gov. Sincerely, Shumaya Ali -S Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/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. June 13, 2019 Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President MRC-X. LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119 Re: K183363 Trade/Device Name: Treace Medical Concepts (TMC) Plating System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 9, 2019 Received: May 13, 2019 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. {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 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. # Shumaya Ali -S Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K183363 Device Name Treace Medical Concepts, Inc (TMC) Snap-Off Screw System #### Indications for Use (Describe) The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as 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, 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 - · fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - Akin type osteotomy Not for spinal use. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ ## 510(k) Summary # Treace Medical Concepts, Inc (TMC) Snap-Off Screw System June 10, 2019 K183363 | Company: | Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra, FL 32081 | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Dawn Norman
Executive Vice President, MRC X, LLC
Phone: 618.604.3064
dawn.norman@mrc-x.com | | Company/Secondary Contact: | Rachel Osbeck
Vice President, Quality Assurance
Treace Medical Concepts, LLC
Phone: 904.373.5940 Ext. 1304
rosbeck@treace.net | | Trade Name: | Treace Medical Concepts, Inc (TMC) Snap-Off Screw 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 | # Device Description: The Treace Medical Concepts, Inc (TMC) Snap -Off Screw System includes self-drilling and selftapping screws provided in diameters of 2.0mm (lengths 10mm-20mm) and 2.7mm(lengths 8mm-20mm). The screws are composed of titanium alloy conforming to ASTM F136. {5}------------------------------------------------ # Indications for Use: The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as 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, 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 - fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - Akin type osteotomy Not for spinal use. ## Substantial Equivalence: | Device | Subject
Treace Medical Concepts,
Inc (TMC) Snap-Off Screw
System | Primary Predicate
Integra SPIN Snap-Off Screw
(K991477) | Secondary Predicate
TMC Compression Screw System
(K172617) | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/
Indications for
Use | The TMC Snap-Off Screw
System is intended for use
for adult and pediatric
patients, as 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,
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: | The Integra SPIN Snap-Off Screw is
indicated for fixing the elective
osteotomies of the mid-foot bones and
the metatarsal and phalanges of the
foot. Examples include:
-Weil Osteotomy
-Unicortical small bone fixation | The TMC Compression Screw
System is intended for use for
adult and pediatric patients, as
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 | {6}------------------------------------------------ | Device | Subject
Treace Medical Concepts,
Inc (TMC) Snap-Off Screw
System | Primary Predicate
Integra SPIN Snap-Off Screw
(K991477) | Secondary Predicate
TMC Compression Screw System
(K172617) | |----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • mono or bicortical
osteotomies
• distal or proximal
metatarsal osteotomies
• weil osteotomy
• fixation of osteotomies for
Hallux Valgus treatment
(such as Scarf, Chevron, etc.)
• Akin type osteotomy
Not for spinal use. | | • 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. | | Material | Ti-6-4; ASTM F136 | Titanium Alloy | Ti-6-4; ASTM F136 | | Finish | Type III Titanium Color
Anodization | Titanium Color Anodization | Type III Titanium Color
Anodization | ## Performance Testing: Performance testing was performed to evaluate the torsion and pull-out properties of the subject device in accordance with ASTM F543. This testing confirmed the subject screws to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw. ## Conclusion: The subject Treace Medical Concepts, Inc (TMC) Snap-Off Screw System components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the following device, previously cleared by the FDA: - Primary Predicate: Integra SPIN Snap-Off Screw (K991477) - Secondary Predicate: Treace Medical Concepts, Inc (TMC) Compression Screw System (K172617) The subject intended use and indications for use are a subset of the secondary predicate intended use and indications for use to ensure only clinically appropriate uses are defined for the design and sizes of the subject screws. The material and overall geometry for the predicate devices are substantially equivalent to those of the subject device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K183363](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K183363) **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