(85 days)
No
The document describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implant used for replacement of a joint to address pain, weakness, and instability caused by rheumatoid, degenerative, or post-traumatic disabilities, which are therapeutic interventions.
No
The device is an implant for replacing the distal radioulnar joint, not for diagnosing conditions.
No
The device description clearly states it is a prosthesis, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (an artificial ulnar head and a sigmoid notch component) intended for replacement of a joint within the human body.
- Intended Use: The intended use is to treat specific conditions of the wrist joint by surgically replacing damaged parts.
This device is an implantable medical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.
Product codes
KXE
Device Description
The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radioulnar joint, distal ulnar head, wrist 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.
0
K061146 (pg 1 of 2)
510(k) Summary
JUL 1 9 2006
.
| Manufacturer: | Small Bone Innovations
1711 South Pennsylvania Ave
Morrisville, PA 19067
215-428-1791 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Ulnar Head Implant |
| Classification name: | Class II, 888.3810 - Prosthesis, Wrist, Hemi-, Ulnar |
| Common/Usual Name: | Ulnar Head Implant |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI
Ulnar Head Implant to be substantially equivalent to other
legally marketed devices. |
| Device Description: | The uHead™ Ulnar Head Replacement prosthesis is
currently approved under 510(k) K010786 and marketed by
Small Bone Innovations. This device is used to treat
patients with rheumatoid, degenerative, or post-traumatic
disabilities presenting the following; pain and weakness of
the wrist joint not improved by conservative treatment,
instability of the ulnar head with x-ray evidence of dorsal
subluxation and erosive changes, and failed ulnar head
resection. The sigmoid notch component is used in
conjunction with the uHead™ device. Dependent upon the
severity of degenerative joint disease and forearm stability,
the sigmoid notch component can be used to restore stabile
wrist function and improve forearm kinematics that is not
always obtainable with the uHead™ prosthesis alone. |
| Intended Use: | The SBI Ulnar Head Implant is intended for replacement of
the distal radioulnar joint following ulnar head resection
arthroplasty: Replacement of the distal ulnar head for
rheumatoid, degenerative, or post-traumatic disabilities
presenting the following; pain and weakness of the wrist
joint not improved by conservative treatment, instability of
the ulnar head with x-ray evidence of dorsal subluxation
and erosive changes, and failed ulnar head resection. |
| Material: | The SBI Ulnar Head Implant is designed from implantable
grades of cobalt chrome (ASTM 1537-94), with CpTi
coating. |
:
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1
KO61146 ( pg.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a caduceus, which is often associated with healthcare. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2006
Small Bone Innovations % Mr. James O'Connor VP, QA/QC & Regulatory Affairs 505 Park Avenue, 14th Floor New York, New York 10022
Re: K061146
Trade/Device Name: SBI Ulnar Head Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: Class II Product Code: KXE Dated: June 13, 2006 Received: June 19, 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 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.
3
Indications for Use
510(k) Number:
Device Name: SBI Ulnar Head Implant
Indications For Use:
The SBI Ulnar Head Implant is intended for replacement of the distal radiouinar joint following unar The SBI Unial Head Infont is intended for reprosition of the distal ulnar head for rheumatoid, degencrative, or posttraumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by and or traumatic disabilities presenting the introwing, pain and with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar 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
Ambare Buchup
Division of General, Restorative, and Neurological Devices
510(k) Number K061146.