(101 days)
Not Found
No
The summary describes a mechanical implant for radial head replacement and does not mention any AI or ML components.
Yes
The device is intended for replacement of the radial head due to degenerative or post-traumatic disabilities, fractures, or failed arthroplasty, which are therapeutic interventions.
No
The device is an orthopedic implant (radial head replacement system) designed for surgical intervention, not for diagnosing medical conditions. Its function is to replace damaged anatomical structures.
No
The device description clearly indicates it is a physical implant (modular heads and stems) used for surgical replacement of the radial head, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 provided text clearly describes a device that is surgically implanted to replace the radial head, a bone in the arm. It is used to treat conditions affecting the radial head and surrounding joints.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Acumed Anatomic Radial Head System and its related components are implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Acumed Anatomic Radial Head System, the Anatomic Radial Head Long Stems, the ARH Slide-Loc' System. and accessories are designed specifically for:
- 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, 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 to be press fit or cemented.
Product codes (comma separated list FDA assigned to the subject device)
KWI
Device Description
The Acumed Anatomic Radial Head Long Stems and the Acumed ARH Slide-Loc "" System include modular heads and stems with accessories to anatomically replace the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial head, radiohumeral joint, 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)
The Anatomic Radial Head Long Stems and the ARH Slide-Loc™ System underwent static and cyclic load testing to characterize their strength.
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.
Not Found
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.
0
Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™System 510(k) Notification
510(k) Summary
Contact Details
| Applicant Name: | Acumed LLC
5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432 |
|-----------------|---------------------------------------------------------------------|
| | Kara Budor, Regulatory Specialist
503-207-1412 |
| Date Prepared: | June 19, 2013 |
Device Name
SEP 30 2013
Trade Name: Acumed Anatomic Radial Head System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc TM System
Common Name: Elbow Hemi -. Prosthesis
Classification: 21 CFR 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis
Class: II
Product Code: K WI
Legally Marketed Predicate Device(s)
The Anatomic Radial Head System cleared in 2004 (K041858) serves as the predicate device.
Device Description
The Acumed Anatomic Radial Head Long Stems and the Acumed ARH Slide-Loc "" System include modular heads and stems with accessories to anatomically replace the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
Intended Use/Indications for use
The Acumed Anatomic Radial Head System, the Anatomic Radial Head Long Stems, the ARH Slide-Loc' System. and accessories are designed specifically for:
1
KI31845
Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System 510(k) Notification
- 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, 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 to be press fit or cemented.
Substantial Equivalence Comparison
The basic comparison between the Anatomic Radial Head Long Stems and the ARH Slide-Loc'ld System to the Acumed Anatomic Radial Head System is given in the table below.
| | Anatomic Radial Head Long Stems
and the ARH Slide-Loc™ System | Predicate |
|-----------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------|
| Material | Titanium alloy per ASTM F136
Cobalt Chromium per ASTM 1537 | Titanium alloy per ASTM F136
Cobalt Chromium per ASTM 1537 |
| Head Diameter | 18mm to 30mm | 20mm to 28mm |
| Stem Diameter | 5mm to 12mm | 6mm to 10mm |
| Stem Length | 25mm to 65mm | 22mm |
| Stem Finish | Grit Blast | Grit Blast |
| Head-to-Stem
Connection | Slide-Loc™ groove and rail connection with
neck component and/or Morse Taper | Morse Taper |
| Head Configuration | Neutral or Left/Right Specific | Neutral |
| Stem Configuration | Neutral or Left/Right Specific | Neutral |
| Provided Sterile /
Non-sterile | Sterile | Sterile |
The Anatomic Radial Head Long Stems, the ARH Slide-Loc™ System, and the Anatomic Radial Head System all include implants and instruments used to replace the radial head. There are some differences, but none of them raise new issues of safety or effectiveness. The Anatomic Radial Head Long Stems and the ARH Slide-Loc™ System are substantially equivalent to the Acumed Anatomic Radial Head System.
Non-clinical Testing
The Anatomic Radial Head Long Stems and the ARH Slide-Loc™ System underwent static and cyclic load testing to characterize their strength.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Acumed. LLC Ms. Kara Budor Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124
September 30, 2013
Re: K131845
Trade/Device Name: Acumed Anatomic Radial Head System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc'" System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: August 30, 2013 Received: September 3, 2013
Dear Ms. Budor:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 -- Ms. Kara Budor
CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Elizabeth L. Frank -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System 510(k) Notification
Page 1/1
Indications for Use
510(k) Number (if known): K131845
Device Name: Acumed Anatomic Radial Head System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc TM System
Indications for Use:
The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-Loc™ System, and accessories are designed specifically for: 1. 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, 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 to be press fit or cemented.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey C. Hanley, Ph.D.
Division of Orthopedic Devices