(340 days)
No
The summary describes a mechanical prosthetic device and its intended use, with no mention of AI or ML technology in its design, function, or performance evaluation.
Yes
The device is a prosthesis intended for the replacement of the radial head, which explicitly falls under the definition of a therapeutic device as it treats degenerative conditions, fractures, and symptomatic sequelae, aiming to restore function and alleviate symptoms.
No
Explanation: The device is a prosthetic implant for replacing the radial head, which is used for treatment rather than diagnosis.
No
The device description explicitly states it is a two-piece modular system comprised of titanium alloy and cobalt chrome components, which are hardware.
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.
- Device Description and Intended Use: The Synthes Radial Head Prosthesis System is a physical implant designed to replace a damaged radial head in the elbow joint. Its intended use is surgical replacement for various conditions affecting the radial head.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens from the patient. The device is implanted directly into the body.
Therefore, based on the provided information, the Synthes Radial Head Prosthesis System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Radial Head Prosthesis System is indicated for the:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral 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
Product codes (comma separated list FDA assigned to the subject device)
KWI
Device Description
The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial head, radiohumeral and/or proximal radio-ulnar 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)
In vitro performance testing demonstrates the ability of the proposed device to withstand the same clinical loads of the radiocapitellar joint.
Macro Surface Analysis (roughness, pore size, pore depth, etc.), Scanning Electron Microscopy (SEM), and X-Ray Photoelectron Spectroscopy (XPS) have been conducted to demonstrate similar macro and micro-surface characteristics in comparison to existing devices. Additionally, a literature review has been conducted demonstrating relating the device surface characteristics to physiological responses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111626, K102067, K100889, K083714, K080615, K111272, K053088, K033984, K072578, K083439
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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JUN 1 9 2012
510(k) Summary
K112030 ( V2)
Date Prepared: June 13, 2011
Sponsor: Synthes Angela F. Lassandro 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6854 Synthes Radial Head Prosthesis System Device Name: Classification: CLASS II, §888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis Product Code: K WI · Biomet ExploR™ Radial Head Prosthesis System (K051385) Predicate Device: Ascension® Modular Radial Head (K032686) Titan Endoskeleton Interbody Fusion Devices (K 11626, K 102067, K 100889, K083714, and K080615) Rhausler Plage Anterior Cervical Fusion System (K111272) Straumann Dental Implant System (K053088 and K033984) Synthes Epoca Titanium Humeral Stem (K072578) Synthes Epoca Titanium Humeral Stem w/ (HA) Coating (K083439) The Synthes Radial Head Prosthesis is a two-piece modular system comprised Device of titanium alloy stem and cobalt chrome head components with an integral Description: screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need. The Synthes Radial Head Prosthesis System is indicated for the: Intended Use: Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation visible on x-ray a. Resistance to conservative treatment b. Primary replacement after fracture of the radial head 2. Symptomatic sequelae after radial head resection 3. Revision following failed radial head arthroplasty
1
KII 2030 (2/2)
Substantial Equivalence:
The proposed Synthes Radial Head Prosthesis has the same indications for use, the same fundamental technological characteristics, and similar materials as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices. In vitro performance testing demonstrates the ability of the proposed device to withstand the same clinical loads of the radiocapitellar joint.
Additionally, the Synthes Radial Head Prosthesis Stems have been shown to have similar surface characteristics to the Titan Endoskeleton Interbody Fusion Devices (K111626, K102067, K100889, K083714, and K080615), Rhausler Plage Anterior Cervical Fusion System (K111272), Straumann Dental Implant System (K053088 and K033984), Synthes Epoca Titanium Humeral Stem (K072578), Synthes Epoca Titanium Humeral Stem w/ (HA) Coating (K083439). Macro Surface Analysis (roughness, pore size, pore depth, etc.), Scanning Electron Microscopy (SEM), and X-Ray Photoelectron Spectroscopy (XPS) have been conducted to demonstrate similar macroand micro- surface characteristics in comparison to existing devices. Additionally, a literature review has been conducted demonstrating relating the device surface characteristics to physiological responses.
Based on the discussed similarities in conjunction with performance testing, physical macro and micro surface analysis, surface chemistry analysis, and literature review the proposed Synthes Radial Head Prosthesis System does not raise any new issues of safety and effectiveness in comparison to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 9 2012
Synthes USA, LLC % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K112030
Trade/Device Name: Synthes Radial Head Prosthesis System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: May 17, 2012 Received: May 21, 2012
Dear Ms. Lassandro:
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. 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
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Page 2 - Ms. Angela F. Lassandro
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Euin Keith
6-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Synthes Radial Head Prosthesis System
Indications for Use:
The Synthes Radial Head Prosthesis System is intended for:
-
- The 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
- The 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
-
b. Resistance to conservative treatment
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radia! head resection
-
- Revision following failed radial head arthroplasty.
Prescription Use X (Per 21 CFR 801.109)
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)
AS
(Division Sign-Of Division of Surgic i. Orthopedic, and Restorative De vices
510(k) Number K112030