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 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.

AI/ML Overview

When evaluating medical device submissions, the FDA scrutinizes various aspects, including performance, safety, and substantial equivalence to legally marketed predicate devices. The document provided, a 510(k) summary for the Treace Medical Concepts (TMC) Snap-Off Screw System (K183363), outlines the device's characteristics and the testing conducted to support its substantial equivalence.

Based on the provided text, the device in question is a bone fixation fastener, specifically the Treace Medical Concepts, Inc (TMC) Snap-Off Screw System. The regulatory classification for this device is Class II, under regulation 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fasteners.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for demonstrating substantial equivalence for this type of device typically involve mechanical performance characteristics that demonstrate the device is as safe and effective as its predicate. Based on the document, the key performance criteria evaluated were:

Acceptance Criteria (Performance Metric)	Reported Device Performance
Torsion properties (ASTM F543)	Confirmed to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw.
Pull-out properties (ASTM F543)	Confirmed to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw.

The document states, "This testing confirmed the subject screws to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw." This implies that the performance of the TMC Snap-Off Screw System fell within the acceptable range or met the same performance standards established by the predicate device for torsion and pull-out strength.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not explicitly state the sample size used for the performance testing (torsion and pull-out). It only mentions that performance testing was performed.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission to the US FDA, the testing would generally be expected to follow US standards, but the origin of the data samples (e.g., specific manufacturing batches) is not detailed. The mechanical testing described is typically conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable. For the mechanical performance testing described (torsion and pull-out), the "ground truth" is established by physical measurements against recognized ASTM standards (ASTM F543), not by expert interpretation. Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of data (e.g., medical imaging) does not apply here.

4. Adjudication Method for the Test Set:

Not Applicable. As the ground truth is established through standardized mechanical testing, there is no need for an adjudication method as would be used in a study involving human interpretation or clinical endpoints.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or implied. The submission focuses on substantial equivalence based on device design, materials, indications for use, and mechanical performance testing against a predicate device. This type of study is more common for diagnostic imaging AI algorithms where human reader performance is a key aspect.

6. Standalone Performance:

A standalone performance evaluation was conducted in terms of mechanical properties. The torsion and pull-out testing evaluates the intrinsic physical properties of the device (the screws themselves) in a simulated environment, independent of human interaction during surgery or in a clinical setting for outcome. The testing aims to show the device's inherent mechanical strength.

7. Type of Ground Truth Used:

The ground truth for the performance testing was based on engineering standards and specifications, specifically ASTM F543 for torsion and pull-out properties. The "truth" is whether the device meets or exceeds the mechanical properties demonstrated by the predicate device when tested according to this standard.

8. Sample Size for the Training Set:

Not Applicable. Since this is a mechanical device, not a machine learning or AI algorithm, there is no "training set" in the context of data used to train a model. The design and manufacturing processes are established based on engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The device's design is based on established engineering principles and the performance of existing predicate devices.

Summary of Key Findings based on the document:

The 510(k) summary demonstrates substantial equivalence of the TMC Snap-Off Screw System to its predicate devices (Integra SPIN Snap-Off Screw and TMC Compression Screw System) primarily through:

Comparison of Indications for Use, Design, Dimensions, and Materials: The subject device's features are compared side-by-side with the predicates to show similarity.
Mechanical Performance Testing: Specifically, torsion and pull-out properties tested according to ASTM F543 were found to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw.

The document does not delve into clinical efficacy studies, multi-reader studies, or large-scale clinical outcome data, as these are generally not required for 510(k) clearance of Class II orthopedic fixation devices when substantial equivalence can be demonstrated through design, material, and mechanical property comparisons to legally marketed predicate devices.

Summary

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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

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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.

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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

Enclosure

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Indications for Use

510(k) Number (if known) K183363

Device Name

Treace Medical Concepts, Inc (TMC) Snap-Off Screw System

Indications for Use (Describe)

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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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 150Ponte Vedra, FL 32081
Primary Contact:	Dawn NormanExecutive Vice President, MRC X, LLCPhone: 618.604.3064dawn.norman@mrc-x.com
Company/Secondary Contact:	Rachel OsbeckVice President, Quality AssuranceTreace Medical Concepts, LLCPhone: 904.373.5940 Ext. 1304rosbeck@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 fixationfastener)
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.

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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	SubjectTreace Medical Concepts,Inc (TMC) Snap-Off ScrewSystem	Primary PredicateIntegra SPIN Snap-Off Screw(K991477)	Secondary PredicateTMC Compression Screw System(K172617)
Intended Use/Indications forUse	The TMC Snap-Off ScrewSystem is intended for usefor adult and pediatricpatients, as indicated forsmall or long bonesrequiring fixation offractures, fracture repair,revision procedures, jointfusions (arthrodesis), bonereconstructions, osteotomy,ligament fixation, andpseudoarthrosis (non-unions) of bones, includingscaphoid and other carpalbones, metacarpals, tarsals,metatarsals, phalanges,ulnar styloid, capitellum,radial head and radialstyloid.In the foot, the followingspecific examples areindicated with screwsappropriate for the size ofthe device:	The Integra SPIN Snap-Off Screw isindicated for fixing the electiveosteotomies of the mid-foot bones andthe metatarsal and phalanges of thefoot. Examples include:-Weil Osteotomy-Unicortical small bone fixation	The TMC Compression ScrewSystem is intended for use foradult and pediatric patients, asindicated for small or long bonesrequiring fixation of fractures,fracture repair, revisionprocedures, joint fusions(arthrodesis), bonereconstructions, osteotomy,ligament fixation, andpseudoarthrosis (non-unions) ofbones, including scaphoid andother carpal bones, metacarpals,tarsals, metatarsals, phalanges,patella, ulnar styloid, capitellum,radial head and radial styloid.In the foot, the following specificexamples are indicated withscrews appropriate for the size ofthe device:• mono or bicortical osteotomies• distal or proximal metatarsalosteotomies· weil osteotomy

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Device	SubjectTreace Medical Concepts,Inc (TMC) Snap-Off ScrewSystem	Primary PredicateIntegra SPIN Snap-Off Screw(K991477)	Secondary PredicateTMC Compression Screw System(K172617)
	• mono or bicorticalosteotomies• distal or proximalmetatarsal osteotomies• weil osteotomy• fixation of osteotomies forHallux Valgus treatment(such as Scarf, Chevron, etc.)• Akin type osteotomyNot for spinal use.		• fusion of themetatarsalphalangeal joint• fixation of osteotomies forHallux Valgus treatment (such asScarf, Chevron, etc.)• Akin type osteotomy• talonavicular fusions• cuboid fusionsNot for spinal use.
Material	Ti-6-4; ASTM F136	Titanium Alloy	Ti-6-4; ASTM F136
Finish	Type III Titanium ColorAnodization	Titanium Color Anodization	Type III Titanium ColorAnodization

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.

Regulation Number and Section

§ 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.