(269 days)
The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile, reusable, Class I and II surgical instruments. The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).
The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw, available in one size with a distal diameter of 11mm, a proximal diameter of 16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm.
This FDA 510(k) premarket notification describes the Artemis Proximal Femoral Nail System, an intramedullary fixation system. It confirms that clinical data was not needed for this device. The information provided heavily relies on comparisons to predicate devices and mechanical testing, rather than studies involving human participants or AI performance. Therefore, many of the requested details about acceptance criteria and study design are not applicable in this context.
Here's a breakdown of the available and unavailable information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Comparability | Subject device (Titanium alloy & CFR PEEK) demonstrated substantial equivalence to predicate (Titanium alloy) through performance characteristics. Reference device used to address material difference. |
| Static Bending of Construct Performance | Comparable to predicate devices. |
| Dynamic Bending of Construct Performance | Comparable to predicate devices. |
| Screw Torque to Failure Performance | Comparable to predicate devices. |
| Compliance with ISO 7206-4 | Successfully underwent testing. |
| Compliance with ASTM F1264 | Successfully underwent testing. |
| Compliance with ASTM F543 | Successfully underwent testing. |
| No new issues of safety or effectiveness | Demonstrated through comparison testing to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is an implantable medical device, and its performance was evaluated through mechanical testing, not clinical studies with human test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement accuracy, not expert human interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic or AI-assisted performance evaluation, not for mechanical testing of an orthopedic implant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-enabled device or a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-enabled device.
7. The type of ground truth used
For the safety and effectiveness assessment, the ground truth was based on:
- Mechanical Testing Standards: Adherence to established international and American standards such as ISO 7206-4, ASTM F1264, and ASTM F543.
- Predicate Device Performance: Performance data from legally marketed predicate devices served as a benchmark for comparison to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This document refers to the evaluation of a medical device (an intramedullary nail system), not an AI algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device evaluation.
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February 19, 2021
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GLW, Inc. % Nancy Lincé President & CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 95483
Re: K201379
Trade/Device Name: Artemis Proximal Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 15, 2021 Received: January 19, 2021
Dear Nancy Lincé:
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.
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
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542 of the Act); 21 CFR 1000-1050.
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-
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 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,
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Artemis Proximal Femoral Nail System
Indications for Use (Describe)
The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510K SUMMARY
| Date Prepared | January 15, 2021 |
|---|---|
| Submitter | GLW, Inc.300 Sylvan AvenueEnglewood Cliff, NJ 07632USA |
| Submitter Contact | Arundhati RadhakrishnanQuality Assurance ManagerPhone: (201) 268-3281Email: arundhati.radhakrishnan@glwmed.com |
| CorrespondentContact | Nancy LincéLincé Consulting, LLCPresident & CEOPhone: (650) 759-6186Email: nlince@linceconsulting.com |
| Device Name | Artemis Proximal Femoral Nail System |
| Common Name | Rod, fixation, intramedullary and accessoriesScrew, fixation, bone |
| Class | Class II |
| Product Code | HSBHWC |
| Classification | 21 CFR 888.3020: Intramedullary fixation rod21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Device Panel | Orthopedic |
| Primary Predicate | K043431 Gamma3 Trochanteric Nail |
| Reference Predicate | K173652 Piccolo Composite Nailing System |
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| Device Description | The Artemis Proximal Femoral Nail System is an intramedullary fracture fixationsystem intended for temporary stabilization of bone segments or fragments in theproximal femur. The system includes single-use, sterile implants (ProximalFemoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile,reusable, Class I and II surgical instruments. The nail and screws are made oftitanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded withcarbon fiber reinforced polymer (CFR PEEK).The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw,available in one size with a distal diameter of 11mm, a proximal diameter of16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximaland distal sections, for the insertion of a Lag Screw and Locking Screw,respectively. The Lag Screw has a diameter of 11mm and is available in variouslengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mmand is available in various lengths ranging from 25mm to 110mm. |
|---|---|
| Indications for Use | The Artemis Proximal Femoral Nail System is indicated for fixation of stableand unstable intertrochanteric fractures, including but not limited to nonunion,malunion and tumor resections. |
| Performance Data | The Artemis Proximal Femoral Nail System successfully underwent mechanicaltesting in accordance with ISO 7206-4, ASTM F1264, and ASTM F543.Performance characteristics for the Artemis Proximal Femoral Nail Systemcomponents included static and dynamic bending of construct, and screw torque tofailure and are comparable to those of predicate devices, thus demonstrating thatthe device is substantial equivalent to the predicate. |
| Clinical Performance Data | Clinical data was not needed for this device. |
| SubstantialEquivalence | Device comparisons demonstrate that the Artemis Proximal Femoral Nail Systemis substantially equivalent to the predicate device in terms of intended use,indications for use, technological characteristics and operating principles. Theprimary difference between the predicate and subject devices is the nail material;the predicate device is constructed from titanium alloy and the subject device isconstructed from titanium alloy and partially over-molded CFR PEEK. Thereference device is included to address the material difference. |
| Conclusion | The information included in the 510(k), which included comparison testing to thepredicate, demonstrates that any minor differences between the subject andpredicate devices do not raise new issues of safety or effectiveness when the deviceis used as intended. |
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.