(157 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional fracture fixation methods. There is no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is described as an "intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur" for various fractures, indicating its use in treating and alleviating a condition, which is a characteristic of a therapeutic device.
No
The device is an intramedullary fracture fixation system used for temporary stabilization of bone segments, not for diagnosis.
No
The device description clearly outlines physical implants (nails, screws, pins) and surgical instruments made of titanium alloy and carbon fiber reinforced polymer. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the fixation of bone fractures in the proximal femur. This is a surgical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description details implants (nails, screws, pins) and surgical instruments used for bone stabilization. These are physical devices used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
Therefore, the Artemis Proximal Femoral Nail System is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HSB, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, intertrochanteric, subtrochanteric, shaft fracture
Indicated Patient Age Range
Not Found
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
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. No clinical data was necessary.
Key Metrics
Not Found
Predicate Device(s)
K201379, K043431, K213005, K200291, K183162
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
510(k) Premarket Notification
Artemis Proximal Femoral Nail System K221489
510(k) Summary
| Submitter | GLW Medical Innovation |
|---|---|
| Address | 300 Sylvan Ave |
| Englewood Cliff, NJ 07632 | |
| Telephone | 917-0794-2583 |
| Contact Person | Arundhati Radhakrishnan |
| Address | 300 Sylvan Ave |
| Englewood 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 accessories |
| Screw, fixation, bone | |
| Panel Code | Orthopaedics/87 |
| Classification | 21 CFR 888.3020 Intramedullary fixation rod |
| 21 CFR 888.3040 Smooth or threaded metallic bone | |
| Class | Class II |
| Product Code | HSB: Rod, fixation, intramedullary and accessories |
| HWC: Screw, fixation, bone |
| Predicate Device (primary) | 510(k) # | Manufacturer |
|---|---|---|
| Artemis Proximal Femoral Nail | ||
| System | 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 Hip | ||
| Fracture Nail | K183162 | Zimmer Biomet |
| Description | 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 |
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
4
510(k) Premarket Notification
Artemis Proximal Femoral Nail System K221489
| K221489
| 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. | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications and | |||||||||||||||||||||
| Intended 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. | | | | | | | | | | | | | | | | | | | | |
| Technological
Characteristics
and Substantial
Equivalence | 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-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 | | | | | | | | | | | | | | | | | | | | | |
| Performance Data | 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. |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |