(157 days)
The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.
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, Proximal Femoral Nail Kit Long, Locking Screw, Lag Screw, and optional anti-rotational locking pins) 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 Nails are available in short or long lengths from 180mm to 440mm and are cylindrical rods with preassembled Set Screws. 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. Optional Anti-rotational Locking Pins are also available to aid in rotational stability.
The provided document describes the FDA 510(k) clearance for the Artemis Proximal Femoral Nail System. This document is a regulatory submission for a medical device that does not involve AI/ML components for diagnostic purposes, and therefore, the acceptance criteria and study proving device performance are based on mechanical and physical properties rather than algorithmic performance on image data.
Therefore, I cannot provide information on the following points:
- 1. A table of acceptance criteria and the reported device performance (in terms of AI/ML metrics): The document reports mechanical testing results, not AI/ML performance metrics.
- 2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML for this device. The testing refers to mechanical and physical properties.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant for this type of device submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
However, based on the provided text, I can infer the "acceptance criteria" and "study proving device meets acceptance criteria" in the context of a non-AI medical device submission:
Acceptance Criteria and Study for the Artemis Proximal Femoral Nail System:
The acceptance criteria for the Artemis Proximal Femoral Nail System are based on its mechanical performance and material characteristics, demonstrating that the device is substantially equivalent to a predicate device. This is a common pathway for Class II medical devices where performance can be validated through engineering and physical testing, rather than clinical studies or AI algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Material Focus):
| Acceptance Category/Criteria | Acceptance Standard (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets relevant ASTM and ISO standards for intramedullary fixation devices. This implies acceptable static and dynamic strength, fatigue resistance, and stability in anticipated loading conditions. Specific standards cited are ASTM F1264 and ASTM F543, and ISO 7206-4. | "The Artemis Proximal Femoral Nail System successfully underwent mechanical testing in accordance with ASTM F1264 and ASTM F543. Performance testing of the Artemis Proximal Femoral Nail System components also included static and dynamic bending of the construct based on ISO 7206-4." (The "successful" completion implies meeting the acceptance thresholds defined by these standards). |
| Material Composition | Identical to predicate device(s) or well-established biocompatible and mechanically sound materials for medical implants. | "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)." (This aligns with common materials for such implants and is stated to be identical to the predicate in the "Comparison" section.) |
| Device Dimensions/Design | Equivalent to predicate device in critical dimensions (diameter, angle, locking options) where relevant to function and safety. | "Materials Identical, Sterilization method Identical, Diameter Identical, Length Short-unchanged Subject Long-additional sizes, Angle Identical, Locking options Short-unchanged Subject Long-identical + additional anti rotational locking screws, Lag screw/locking screw Identical, Method of fixation Identical, Mechanics of action Identical." (The "additional sizes" for the long nail kit and "additional anti rotational locking screws" are acknowledged but presumably deemed not to raise new safety/effectiveness questions based on the testing performed, implying the design variations still meet the overall safety profile). |
| Sterilization | Validated to be consistent with predicate device or industry standards to ensure sterility. | "Sterilization method Identical" (to the predicate device). |
| Biocompatibility | Materials used are biocompatible as per predicate device or established standards. | Implied by "Materials Identical" to the predicate, which would have undergone biocompatibility assessment. |
| Intended Use | The device is suitable for the stated indications for use. | "The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections. Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch." (The submission argues that the technological characteristics do not raise different questions of safety and effectiveness compared to the predicate, even with the expanded long nail kit indication, implying the mechanical testing supports this broader claim). |
| Substantial Equivalence | Demonstrated through comparison of indications, materials, and technological characteristics to a legally marketed predicate device, without raising new questions of safety or effectiveness. | "Documentation was provided to demonstrate that the Subject device, Artemis Proximal Femoral Nail System is substantially equivalent to the primary predicate Artemis Proximal Femoral Nail System (K201379)... Based on the indications for use, technological characteristics, materials, and comparison to the predicate devices, the subject Artemis Proximal Femoral Nail System has been shown to be substantially equivalent to a legally marketed predicate device." |
Study Proving the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is primarily non-clinical performance testing, specifically mechanical testing.
- Type of Study: Mechanical Testing
- Specific Tests Conducted:
- ASTM F1264: Standard Specification for Extramedullary Splints and Bone Plates (likely referenced for general principles or associated components, though the primary device is intramedullary).
- ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
- ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components. (This standard refers to hip prostheses, but its principles for static and dynamic bending of constructs are applied to the femoral nail system).
- Data Provenance: The nature of mechanical testing means the "data provenance" is derived from laboratory tests conducted on samples of the device itself. This is typically done in a controlled, prospective manner. Country of origin of the data is not specified but would be the location of the GLW Medical Innovation's testing facilities or contracted labs.
- Sample Size Used for the Test Set: While not explicitly stated for each test, mechanical testing typically involves a sufficient number of samples (e.g., typically 3-6 or more samples per test condition, depending on the standard and variability) to ensure statistical significance and reproducibility of results for the physical properties being evaluated.
- Ground Truth: For mechanical testing, the "ground truth" is defined by the acceptance criteria established within the referenced ASTM and ISO standards. The device 'passes' if its performance (e.g., strength, fatigue life) meets or exceeds the minimum requirements specified in these industry standards for similar devices. There are no human experts establishing ground truth in terms of diagnostic interpretation or clinical outcomes for this specific submission.
- Clinical Data: The submission explicitly states: "No clinical data was necessary." This reinforces that the substantial equivalence determination was based entirely on non-clinical performance data (mechanical testing and comparison to the predicate).
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October 27, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GLW, Inc. % Cheryl Wagoner Principal Consultant Wagoner Consulting LLC 5215 Crosswinds Drive Wilmington, North Carolina 28409
Re: K221489
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: September 29, 2022 Received: September 30, 2022
Dear Cheryl Wagoner:
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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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,
For Victoria Lilling, M.D. 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) K221489
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.
Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.
| 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) Premarket Notification
Artemis Proximal Femoral Nail System K221489
510(k) Summary
| Submitter | GLW Medical Innovation |
|---|---|
| Address | 300 Sylvan AveEnglewood Cliff, NJ 07632 |
| Telephone | 917-0794-2583 |
| Contact Person | Arundhati Radhakrishnan |
| Address | 300 Sylvan AveEnglewood Cliff, NJ 07632 |
| Telephone | 201-268-3281 |
| Arundhati.radhakrishnan@glwmed.com | |
| Date Prepared | October 24, 2022 |
| Trade Name | Artemis Proximal Femoral Nail System |
| Common Name | Rod, fixation, intramedullary and accessoriesScrew, fixation, bone |
| Panel Code | Orthopaedics/87 |
| Classification | 21 CFR 888.3020 Intramedullary fixation rod21 CFR 888.3040 Smooth or threaded metallic bone |
| Class | Class II |
| Product Code | HSB: Rod, fixation, intramedullary and accessoriesHWC: Screw, fixation, bone |
| Predicate Device (primary) | 510(k) # | Manufacturer |
|---|---|---|
| Artemis Proximal Femoral NailSystem | K201379 | GLW Medical Innovation |
| Predicate Device (additional) | 510(k) # | Manufacturer |
| Gamma 3 TNail System | K043431 | Stryker |
| Apollo Ankle Plating System | K213005 | GLW Medical Innovation |
| CREED Cannulated Screws | K200291 | GLW Medical Innovation |
| Zimmer Biomet Affixus HipFracture Nail | K183162 | Zimmer Biomet |
| Description | The Artemis Proximal Femoral Nail System is an intramedullary fracturefixation system intended for temporary stabilization of bone segments orfragments in the proximal femur. The system includes single-use, sterileimplants (Proximal Femoral Nail Kit Short, Proximal Femoral Nail KitLong, Locking Screw, Lag Screw, and optional anti-rotational lockingpins) 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 titaniumalloy nail is partially over-molded with carbon fiber reinforced polymer(CFR PEEK).The Artemis Nails are available in short or long lengths from 180mm to440mm and are cylindrical rods with preassembled Set Screws. The Nailis designed with holes, at the proximal and distal sections, for the |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) Premarket Notification
Artemis Proximal Femoral Nail System K221489
| K221489insertion 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. Optional Anti-rotational Locking Pins are also available to aid in rotational stability. | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications andIntended Use | 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.Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch. | ||||||||||||||||||||
| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Subject device, Artemis Proximal Femoral Nail System is substantially equivalent to the primary predicate Artemis Proximal Femoral Nail System (K201379). The subject and predicate (K201379) are identical in intended use, material, and manufacturing processes. The difference in the indications for use use statements includes the addition of the subject long nail kit. Additionally, the proposed changes to technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device. | ||||||||||||||||||||
| Comparison Materials Identical Sterilization method Identical Diameter Identical Length Short-unchangedSubject Long-additional sizes Angle Identical Locking options Short-unchangedSubject Long-identical + additionalanti rotational locking screws Lag screw/locking screw Identical Method of fixation Identical Mechanics of action Identical |
| Performance Data | The Artemis Proximal Femoral Nail System successfully underwentmechanical testing in accordance with ASTM F1264 and ASTM F543.Performance testing of the Artemis Proximal Femoral Nail Systemcomponents also included static and dynamic bending of the constructbased on ISO 7206-4. |
|---|---|
| No clinical data was necessary. | |
| Conclusion | |
| Based on the indications for use, technological characteristics, materials, and comparison to the predicate devices, the subject Artemis Proximal Femoral Nail System has been shown to be substantially equivalent to a legally marketed predicate device. |
§ 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.