(191 days)
Not Found
No
The summary describes a mechanical screw system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a screw system intended for fixation of bones, which is a structural rather than therapeutic function.
No
The device description clearly states it is a screw system used for fixation of fractures, repair, and other orthopedic procedures, which are considered therapeutic interventions, not diagnostic ones.
No
The device description clearly states it includes physical screws made of titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is a system of screws intended for the fixation of bones in various anatomical locations. This is a surgical implant used directly within the body for structural support and repair.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its function is purely mechanical and therapeutic.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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, 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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small or long bones, scaphoid, carpal bones, metacarpals, tarsals, phalanges, ulnar styloid, capitellum, radial head, radial styloid, foot
Indicated Patient Age Range
adult and pediatric patients
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
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.
Key Metrics
Not Found
Predicate Device(s)
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 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) |
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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.