(30 days)
Use of the Modular Radial Head Implant may be considered 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:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .
The EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.
This document describes a 510(k) submission for the EVOLVE® Modular Radial Head, specifically for an extension to include additional size stems and heads. The submission asserts substantial equivalence to a previously cleared device (K991915).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria or a study that directly reports the performance of the EVOLVE® Modular Radial Head against such criteria. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device.
The "acceptance criteria" in this context are implicitly met if the new sizes are shown to be substantially equivalent to the predicate device in terms of design features, intended use, operating principles, and materials, with adequate support from materials data and testing results.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use | The intended use of the extended EVOLVE® Modular Radial Head is identical to the predicate device (K991915). This includes replacement for degenerative/post-traumatic disabilities, primary replacement after radial head fracture, symptomatic sequelae after radial head resection, and revision following failed radial head arthroplasty. |
| Type of Interface | Substantially equivalent to the predicate device (K991915). |
| Operating Principles | Substantially equivalent to the predicate device (K991915). |
| Shelf Life | Substantially equivalent to the predicate device (K991915). |
| Design Features (for new sizes) | The design features of the additional sizes are identical to the previously submitted and cleared stems and heads under 510(k) K991915. |
| Materials Data and Testing Results | Safety and effectiveness are "adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification." (Specific details of these tests are not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a clinical trial or performance study involving patients. The evaluation is based on engineering principles and comparison to a predicate device. Therefore, no information is available regarding:
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of regulatory submission. There was no "ground truth" to establish through expert consensus as it's not a diagnostic or AI-based device requiring such validation. The regulatory review is performed by FDA personnel based on submitted technical documentation.
4. Adjudication Method for the Test Set
This is not applicable as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation, often with AI assistance, to assess the impact of AI on reader performance. The EVOLVE® Modular Radial Head is an implantable orthopedic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This is also relevant for AI/diagnostic algorithms. The device itself is a physical implant; it does not have an "algorithm-only" performance to evaluate in this context.
7. The Type of Ground Truth Used
As this is a mechanical medical device and the submission focuses on substantial equivalence based on engineering and materials data, the concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic or prognostic devices is not directly relevant or used in the provided summary. The "ground truth" for demonstrating safety and effectiveness for a mechanical device is typically established through:
- Design specifications and analysis: Ensuring the design meets engineering requirements.
- Material properties: Verifying materials meet established standards.
- Mechanical testing: Bench testing for strength, fatigue, wear, etc. (Though specific results are not detailed in this summary, they are mentioned as being provided).
- Clinical history of the predicate device: The safety and effectiveness of the predicate device (K991915) serves as the primary "ground truth" indirectly, as the new device is demonstrated to be identical or substantially equivalent.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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APR 1 9 2006
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, sans-serif font. Below the word is a graphic of three arrows pointing to the right. Underneath the arrows is the alphanumeric code "K060731" in a handwritten style font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® Modular Radial Head.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | March 17, 2006 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | EVOLVE® Modular Radial Head |
| Common Name: | Modular Radial Head |
| Classification Name and Reference: | 21 CFR 888.3170 Elbow joint radial (hemi elbow) polymer prosthesis – Class II |
| Device Product Code and Panel Code: | Orthpedics/87/KWI |
DEVICE INFORMATION
A. INTENDED USE
Use of the Modular Radial Head Implant may be considered 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:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .
B. DEVICE DESCRIPTION
The EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.
headquarters
Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002
901.867.9971 pho
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada
011.81.3.3538.0474 Japan
011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
1.49.4161.745130 Germany
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, type of interface, operating principles, shelf life, and design features of the EVOLVE® Radial Head Implant are substantially equivalent to the head component covered under the EVOLVE® Modular Radial Head 510(k): K991915. Additionally, the safety and effectiveness of the EVOLVE® Radial Head Implant is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Wright Medical Technologies, Inc. c/o Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K060731
Trade/Device Name: EVOLVE Modular 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: March : 7, 2006 Received: March 20, 2006
Dear Mr. Reed:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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 CTR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set
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Page 2 - Mr. Wesley L. Reed
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Leonard
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K060731 510(k) Number (if known):
Device Name: EVOLVE® Modular Radial Head
Indications For Use:
Use of the Modular Radial Head Implant may be considered 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:
- a. joint destruction and/or subluxation visible on x-ray; and/or
- b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Huler Lemusica
1 of 1
(Division SELECT == C == 1 Division of General, Restorativ. and Neurological Devices
510(k) Number K100731
§ 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.