(47 days)
Not Found
Not Found
No
The document describes a physical implant (radial head prosthesis) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to replace the proximal end of the radius for degenerative or post-traumatic disabilities, fracture, and symptomatic sequelae, aiming to alleviate pain, crepitation, and improve motion. These are all therapeutic functions.
No
Explanation: The SBi Lateral Assembly rHead is described as a replacement prosthesis for the radial head, explicitly stating its purpose for surgical replacement rather than diagnosis. The mention of "x-ray" refers to how the condition is visible, not how the device itself performs diagnosis.
No
The device description clearly states it is a prosthesis consisting of a cobalt chromium stem and head, which are physical hardware components.
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. They are used outside the body.
- Device Description: The SBi Lateral Assembly rHead is a prosthetic implant designed to be surgically inserted into the human body to replace a damaged part of the radius bone.
- Intended Use: The intended use clearly states it's for "replacement of the proximal end of the radius" due to various conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the SBi Lateral Assembly rHead is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Radial Head Implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, post- traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
a. Joint destruction 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.
Product codes
KWI
Device Description
The SBi Lateral Assembly rHead prosthesis consists of a cobalt chromium stem and head. The stem of the implant is coated with CPTi coating and is designed to be inserted into the shaft of the proximal radius. The head of the implant articulates with the capitellum. The implant is available in several sizes, each of which can be used in right or left hands. A range of trial sizers for each type of implant is available to aid in bone preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal end of the radius
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K062898
NOV 1 3 2006
.
510(k) Summary
| Manufacturer: | rms Company
8600 Evergreen Boulevard
Minneapolis, MN 55433
763-786-1520 - Office
763-783-5073 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
James O' Connor
505 Park Avenue, 14th Floor
New York, NY 10022
joconnor@totalsmallbone.com
215-428-1791 - Office
212-750-2112 - Fax |
| Proprietary Name: | SBI Lateral rHead Implant |
| Classification name: | Class II, 888.3170 - prosthesis, elbow, hemi-, radial,
polymer |
| Common/Usual Name: | Elbow joint radial (hemi-elbow) polymer prosthesis |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI
Lateral rHead Implant to be substantially equivalent to
other legally marketed devices. |
| Device Description: | The SBi Lateral Assembly rHead prosthesis consists of a
cobalt chromium stem and head. The stem of the implant is
coated with CPTi coating and is designed to be inserted
into the shaft of the proximal radius. The head of the
implant articulates with the capitellum. The implant is
available in several sizes, each of which can be used in
right or left hands. A range of trial sizers for each type of
implant is available to aid in bone preparation. |
| Intended Use: | The Radial Head Implant is intended for replacement of the
proximal end of the radius: |
| | 1. Replacement of the radial head for degenerative, post-
traumatic disabilities presenting pain, crepitation and
decreased motion at the radio-humeral and or proximal
radio-ulnar joint with:
a. Joint destruction or subluxation visible on x-ray.
b. Resistance to conservative treatment. |
1
-
- Primary replacement after fracture of the radial head.
-
- Symptomatic sequelae after radial head resection.
Material:
ASTM F-1537 wrought cobalt chromium molybdenum alloy for surgical implants ASTM F-1580 titanium powders for coating of surgical implants
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 3 2006
Small Bone Innovations % Mr. James O'Connor 505 Park Avenue, 14th Floor New York, New York 10022
Re: K062898
Trade/Device Name: SBI Lateral rHead Implant Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis. Regulatory Class: II Product Code: K WI Dated: September 15, 2006 Reccived: September 27, 2006
Dear Mr. O'Connor:
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 ideinetions for use stated in the enclosure) to legally marketed predicate devices marketed in intentive 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 revire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FIA may publish further announcements concerning your device in the Federal I fir and
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 occur product radiation control provisions (Sections 531-542 of the Act), 21 CFR 100-1050.
3
Page 2- Mr. James O'Connor
This letter will allow you to begin marketing your device as described in your Section 5 00(k) This letter will anow you to ocgin manketing your and equivalence of your device to a legally prematics notification. "The I DA Inturing of cassession on the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your don 2011-01-0120. Also, please note the regulation entitled, Colliact the Office of Compliance at (210) 216 - 216 - 21 807.97). You may obtain " Misorallung by relective to premarker notificansmission of Small of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ocusanter Flowww.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buskup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: KO6 2898
Device Name: SBI Lateral rHead
Indications For Use:
The SBi Lateral Assembly rHead is intended for replacement of the proximal end of the radius:
-
- 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 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
Prescription Use V (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)
Page 1 of 1
Jarbare Buchum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
06,2898