(70 days)
No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the replacement of a body part (radial head) to treat degenerative or post-traumatic disabilities, which falls under the definition of a therapeutic device.
No
The device is a prosthesis intended for replacement of the radial head, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a two-piece cobalt alloy prosthesis consisting of a stem and a head, which are physical hardware components.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ExploR™ Modular Radial Head Replacement Device is a prosthetic implant designed to replace a damaged radial head in the elbow joint. It is surgically implanted into the body.
- Lack of Specimen Analysis: The description and intended use clearly indicate that this device does not analyze any biological specimens. It is a physical replacement for a bone structure.
Therefore, based on the provided information, the ExploR™ Modular Radial Head Replacement Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ExploR™ Modular Radial Head Replacement Device is intended 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
- 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 device is intended for single use with or without bone cement.
Product codes
KWI
Device Description
The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
radial head, radio-humeral joint, proximal radio-ulnar joint, elbow
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: Engineering analysis and mechanical testing were provided.
Clinical Testing: None provided as a basis of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Modular Radial Head Replacement Device (K040611), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644), Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
AUG 5 - 2005
K051385 P 1/1
Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics Inc. The word "BIOMET" is in large, bold, sans-serif font, with each letter enclosed in a rectangular box except for the "O", which is a circle. Below "BIOMET" is the text "ORTHOPEDICS INC." in a smaller, thinner font.
510(k) Summar
Applicant/Sponsor: Biomet Manufacturing Corp. 56 Bell East Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Contact Person: Patricia Sandborn Beres Telephone: (574) 267-6639
Proprietary Name: ExploR™ Modular Radial Head Replacement Device
Common Name: Elbow hemi-prosthesis
Classification Name: Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)
Leqally Marketed Devices to Which Substantial Equivalence Is Claimed: Modular Radial Head Replacement Device (K040611), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915)
Device Description: The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.
Intended Use: The ExploR™ Modular Radial Head Replacement Device is intended 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:
- Joint destruction and/or subluxation visible on x-ray a)
- 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 device is intended for single use with or without bone cement.
Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Modular Radial Head Replacement Device are similar to the predicate devices.
Non-Clinical Testing: Engineering analysis and mechanical testing were provided.
Clinical Testing: None provided as a basis of substantial equivalence.
MAILING ADDRESS PO. Box 58" Warsaw, IN 46581 0588
.
SHIPPING ADDRESS s(s E. Bell Drive Warsaw, IN 16582
1
OFFICE 574.26 ' (66.30)
Image /page/0/Picture/25 description: The image contains the word "FAX" at the top. Below that is a series of numbers, "574.26 7 81 37". There is also a time stamp of "1:18" in the upper left corner.
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1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
AUG 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K051385
Trade/Device Name: ExploR™ Modular Radial Head Replacement Device Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: May 25, 2005 Received: May 27, 2005
Dear Ms. Beres:
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.
2
Page 2 – Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retet natification. The FDA finding of substantial equivalence of your device to a legally premated 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,
Atyl Rlwrla
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
ExploR™ Modular Radial Head Replacement Device ---Device Name:
Indications For Use: The ExploR™ Modular Radial Head Replacement Device is intended 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
- 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 device is intended for single use with or without bone cement.
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)
Stpt Rhodes
Page 1 of 1
(Division' Division of General, Restorative and Neurological Devices
510(k) Number K051385