(27 days)
Not Found
No
The device description and performance studies focus solely on the mechanical components and physical properties of the orthopedic fixation system. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
This device is an orthopedic fixation system used for bone fractures, fusions, or reconstructions, which falls under the definition of a therapeutic device.
No
This device is an orthopedic intraosseous staple system used for fixation of bone fractures, fusions, or bone reconstructions. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical implants (staples and screws) and accessory instruments, indicating it is a hardware-based medical device system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- StealthFix System Function: The StealthFix Intraosseous Fixation System is a surgical implant used to physically fix bone fractures, fusions, or for bone reconstructions. It is directly implanted into the bone to provide structural support.
- Lack of Specimen Analysis: The description of the StealthFix system does not mention any analysis of biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the StealthFix Intraosseous Fixation System is an orthopedic surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Product codes
JDR, HWC
Device Description
The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or foot
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device. Mechanical testing was not required to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device. An engineering analysis was performed to compare the subject and predicate screws to demonstrate that the new screate a new worst case for screw mechanical strength (cross sectional area) or screw fixation (thread substrate interface area). Device usability was evaluated through cadaveric testing.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device.
Conclusions:
The StealthFix Intraosseous Fixation System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Medartis Inc. Chelsea Kozior Regulatory Affairs Manager 1195 Polk Drive Warsaw, Indiana 46582
Re: K232324
Trade/Device Name: StealthFix Intraosseous Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: August 2, 2023 Received: August 3, 2023
Dear Chelsea Kozior:
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.
1
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 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.
Christopher Ferreira -S
for
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
StealthFix Intraosseous Fixation System
Indications for Use (Describe)
The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
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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K232324 Page 1 of 2
510(k) Summary
Prepared on: 2023-08-28 21 CFR 807.92(a)(1)
Contact Details
| Applicant Name | Medartis Inc. | |
|---|---|---|
| Applicant Address | 1195 Polk Drive Warsaw IN 46582 United States | |
| Applicant Contact Telephone | 610-731-8650 | |
| Applicant Contact | Ms. Chelsea Kozior | |
| Applicant Contact Email | Chelsea.Kozior@medartis.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | StealthFix Intraosseous Fixation System | |
| Common Name | Single/multiple component metallic bone fixation appliances and | |
| accessories | ||
| Classification Name | Staple, Fixation, Bone | |
| Regulation Number | 888.3030 | |
| Product Code | JDR | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K220181 | StealthFix Intraosseous Fixation System | JDR |
Device Description Summary
The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
The StealthFix Intraosseous Fixation System is indicated for fixation of bone reconstructions, including: · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
4
Indications for Use Comparison
The subject device has the same intended use and Indications for Use as the predicate cleared under K220181.
Technological Comparison
The subject device staple implants are identical in design and materials to the predicate device cleared under K220181. The subject device screw implants and instruments have no change in materials. All screw implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device instruments are manufactured using Stainless Steel in conformance with ASTM F899. The subject device uses the same operating principles as the predicate device.
The subject device modifications are to provide additional screw implants and to modify the design of system instrumentation. The predicate device contains only partially threaded screws whereas the subject device contains both partially and fully threaded 3.5mm screws. These device modifications do not raise different types of safety and effectiveness questions. The design control process according to 21 CFR 820.30 was followed to ensure the device modifications do not create and function as intended.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Testing:
Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device. Mechanical testing was not required to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device. An engineering analysis was performed to compare the subject and predicate screws to demonstrate that the new screate a new worst case for screw mechanical strength (cross sectional area) or screw fixation (thread substrate interface area). Device usability was evaluated through cadaveric testing.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device.
Conclusions:
The StealthFix Intraosseous Fixation System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.
21 CFR 807.92(a)(5)