(142 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a radial head implant, with no mention of AI or ML.
Yes.
The device replaces the radial head due to degenerative or post-traumatic disabilities, aiming to alleviate pain, crepitation, and improve motion, which are therapeutic goals.
No
This device is a radial head implant used for replacement, not for diagnosing medical conditions. It is a therapy device.
No
The device description clearly states it is a "one-piece, stemmed radial head replacement" manufactured from "wrought CoCrMo alloy" and includes "accessory instruments." This indicates a physical implant and surgical tools, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Ignite Orthopedics Revolution Radial Head is a surgical implant designed to replace the radial head in the elbow joint. Its intended use is to treat musculoskeletal conditions and injuries.
- Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples from the patient. It is a physical component implanted into the body.
Therefore, the Revolution Radial Head falls under the category of a medical device (specifically, a surgical implant), but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ignite Orthopedics Revolution Radial Head is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWI
Device Description
The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radio-humeral and/or proximal radio-ulnar joint (elbow joint)
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:
Bending stress analysis was used to compare the strength of the Revolution Radial Heads with the strength of the predicate device. This analysis confirmed that the strength of the worst case Revolution Radial Head is greater than the strength of the worst case predicate device and is adequate for its intended use. Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ignite Orthopedics, Inc. Russ Parrott VP of Research and Development 210 North Buffalo Street Warsaw, Indiana 46580
Re: K183618
Trade/Device Name: Revolution Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: December 21, 2018 Received: December 26, 2018
Dear Russ Parrott:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
May 17, 2019
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
CAPT Raquel Peat, PhD, MPH, USPHS For: Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183618
Device Name Revolution Radial Head
Indications for Use (Describe)
The Ignite Orthopedics Revolution Radial Head is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
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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510(k) Summary - K183618 | |
---|---|
Prepared: | December 21, 2018 |
Submitter: | Ignite Orthopedics, Inc. |
210 North Buffalo Street | |
Warsaw, IN 46580 | |
Contact: | Russ Parrott |
VP of Research and Development | |
Phone: 574.527.2864 | |
russ.parrott@igniteorthopedics.com | |
Proprietary Name: | Revolution Radial Head |
Common Name: | Radial Head |
Classification: | 21 CFR §888.3170: Elbow joint radial (hemi elbow) polymer prosthesis; |
Class II | |
Product Code: | KWI |
Predicate Device: | Wright Medical Evolve Modular Radial Head, K060731 |
Device Description:
The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
4
Intended Use / Indications:
The Ignite Orthopedics Revolution Radial Head is indicated for:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting ● pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- resistance to conservative treatment. o
- Primary replacement after fracture of the radial head. ●
- Symptomatic sequelae after radial head resection. ●
- Revision following failed radial head arthroplasty. ●
Summary of Technologies/Substantial Equivalence:
The Revolution Radial Head is substantially equivalent to the predicate devices in regards to its intended use and indications, 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.
Non-Clinical Testing:
Bending stress analysis was used to compare the strength of the Revolution Radial Heads with the strength of the predicate device. This analysis confirmed that the strength of the worst case Revolution Radial Head is greater than the strength of the worst case predicate device and is adequate for its intended use. Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of