(136 days)
The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.
The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.
Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Arthrosurface Bone Screws:
It's important to note that this document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to existing devices, rather than proving a new device meets specific, novel acceptance criteria through a clinical trial. Therefore, the "study" described is primarily non-clinical testing to show equivalence in performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for bone screws, the "acceptance criteria" are generally derived from recognized industry standards for mechanical performance and safety, and the "reported device performance" are the results demonstrating compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Arthrosurface Bone Screws) |
|---|---|
| ASTM F543: Torque to failure requirements | Demonstrated compliance with ASTM F543 |
| ASTM F543: Insertion/removal torque requirements | Demonstrated compliance with ASTM F543 |
| ASTM F543: Axial pullout force requirements | Demonstrated compliance with ASTM F543 |
| USP <85>, <161>, AAMI ST72:2002/R2010: Bacterial Endotoxins Test (limit 0.5 EU/mL or 20 EU/Device) | Kinetic Chromogenic LAL Test Result: Meets the standard limit |
| Substantial Equivalence: Similar indications for use | Confirmed to have similar indications to predicates |
| Substantial Equivalence: Similar device designs | Confirmed to have similar designs to predicates |
| Substantial Equivalence: Same operating principle | Confirmed to use the same operating principle as predicates |
| Substantial Equivalence: Same manufacturing materials (Stainless Steel, Titanium) | Confirmed to use the same materials as predicates |
| Substantial Equivalence: Same packaging/sterilization methods | Confirmed to use the same packaging/sterilization methods as predicates |
Note: The document states "demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices" and "The safety and effectiveness... is adequately supported by the substantial equivalence and performance testing information," implying that the device met the established criteria within these standards.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of screws or tests performed for each non-clinical test (torque, pullout, LAL). It typically refers to "the Arthrosurface Bone Screws" as a general product line being tested.
- Data Provenance: The data is generated from non-clinical laboratory testing conducted by the manufacturer, Arthrosurface, Inc. The location of the testing is not specified beyond the company's address in Franklin, Massachusetts. This is prospective testing conducted specifically for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of this 510(k) submission for bone screws.
- Ground truth is typically established through expert consensus or clinical outcomes for diagnostic or AI-driven devices. For implantable mechanical devices like bone screws, "ground truth" is determined by objective physical and chemical testing against established engineering and biocompatibility standards (e.g., ASTM, USP). There are no human experts "establishing ground truth" in the way one would for image interpretation.
4. Adjudication Method for the Test Set
This section is not applicable. As described above, the "test set" involves physical and chemical property measurements against predefined international standards, not subjective assessments requiring adjudication among human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
- MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to compare the performance of human readers with and without AI assistance. This device is a mechanical bone fixation fastener, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this concept is not applicable.
- This question pertains to AI/software as a medical device (SaMD). The Arthrosurface Bone Screw is a physical implantable device. There is no "algorithm" or standalone software performance to evaluate in this context.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance testing is based on:
- Established engineering standards: Specifically, ASTM F543 for mechanical properties (torque to failure, insertion/removal torque, axial pullout force).
- Biocompatibility and sterility standards: United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies.
8. The Sample Size for the Training Set
This section is not applicable.
- There is no "training set" in the context of a 510(k) submission for a mechanical bone screw. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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December 22, 2017
Arthrosurface, Inc. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K172383
Trade/Device Name: Arthrosurface Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 10, 2017 Received: November 14, 2017
Dear Ms. Wilson:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172383
Device Name Arthrosurface Bone Screws
Indications for Use (Describe)
The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.
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 Section 5
| 510(k) Owner: | Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038Tel: 508.520.3003Fax: 508.528.4604 |
|---|---|
| Contact: | Dawn WilsonVP, Quality & Regulatory |
| Date of Preparation: | December 14, 2017 |
| Trade Name: | Arthrosurface Bone Screws |
| Common Name: | Screw, Fixation, Bone |
| Device: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification Regulation: | Regulation Number 21 CFR 888.3040 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HWC |
Device Intended Use
The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.
Device Description
The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.
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Substantial Equivalency:
The intended use, materials, and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed predicate devices:
| Primary Predicate(s) | |
|---|---|
| • Arthrex Low Profile Screws | K143614 |
| Additional Predicate(s) | |
| • Arthrex Fracture System | K112437 |
| • Arthrex Low Profile Screws | K103705 |
| • Synthes Cortical Screws | K112583 |
| • Arthrosurface Bone Screws | K161539 |
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices:
- Has similar indications for use ●
- Has similar device designs
- Uses the same operating principle
- Is manufactured using the same Stainless Steel and Titanium implant materials
- o Is packaged and sterilized using the same materials and processes
The following non-clinical testing was performed on the Arthrosurface Bone Screws:
- Torque to failure, insertion/removal torque and axial pullout force tests per ASTM F543
- . A Kinetic Chromogenic LAL Test for Devices that meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
The safety and effectiveness of using the Arthrosurface Bone Screws is adequately supported by the substantial equivalence and performance testing information provided within this Premarket Notification. The results have demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices.
§ 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.