(118 days)
Not Found
No
The summary describes a physical prosthesis and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is a prosthesis indicated for degenerative or posttraumatic disabilities of the thumb basal joint, which qualifies it as a therapeutic device.
No
The device is a prosthesis indicated for treating degenerative or posttraumatic disabilities of the thumb basal joint, rather than diagnosing them.
No
The device description explicitly states "The EXTREMITY MEDICAL Trapezium 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 and Intended Use: The provided information clearly describes a prosthesis intended for surgical implantation to treat degenerative or posttraumatic disabilities of the thumb basal joint. It is a physical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:
- Localized pain and palpable crepitation at the base of the thumb on the "grind test" -(circumduction with axial compression of the thumb)
- -Decreased motion, pinch, and grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
- Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity
Product codes
KYI
Device Description
The EXTREMITY MEDICAL Trapezium Prosthesis
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
thumb basal joint, trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, distal joints of thumb
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)
Wright Medical, Metallic CMC Spherical Implant K960534, Wright Medical, Orthosphere Ceramic Spherical Implant, K030319, Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490, Wright Medical, Swanson Titanium Carpal Lunate Implant, K864491, Wright Medical, TIE-IN Trapezium, K033529, Wright Medical, Trapezium Implant, K781756, Ascension Orthopedics, PyroSphere, K042690, Ascension Orthopedics, PyroCarbon Lunate, K080997
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
K092548 1/2
ニ
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DEC 1 5 2009
510(k) Summary of Safety and Effectiveness:
EXTREMITY MEDICAL Implant System
| Submitter: | EXTREMITY MEDICAL LLC |
|---|---|
| 300 Interpace Parkway | |
| Suite 410 | |
| Parsippany, NJ 07054 | |
| Contact Person | Jamy Gannoe |
| President | |
| Phone: 973-588-8980 | |
| Email: jgannoe@extremitymedical.com | |
| Date Prepared | August 18, 2009 |
| Trade Name | EXTREMITY MEDICAL Trapezium Prosthesis |
| Classification Name | |
| and Number | 21 CFR 888.3770 |
| Product Code | KYI |
| Predicate Devices | Wright Medical, Metallic CMC Spherical Implant K960534 |
| Wright Medical, Orthosphere Ceramic Spherical Implant, | |
| K030319 | |
| Wright Medical, Swanson Titanium Carpal Scaphoid Implant, | |
| K864490 | |
| Wright Medical, Swanson Titanium Carpal Lunate Implant, | |
| K864491 | |
| Wright Medical, TIE-IN Trapezium, K033529 | |
| Wright Medical, Trapezium Implant, K781756 | |
| Ascension Orthopedics, PyroSphere, K042690 | |
| Ascension Orthopedics, PyroCarbon Lunate, K080997 | |
| Device Description | The EXTREMITY MEDICAL Trapezium Prosthesis |
| Indications for use | The Extremity Medical Trapezium Prosthesis is indicated for |
| use in degenerative or post-traumatic (e.g. following an old | |
| Bennett fracture) disabilities of the thumb basal joint with: |
- Localized pain and palpable crepitation at the base of the
thumb on the "grind test" (circumduction with axial
compression of the thumb) - Decreased motion, pinch, and grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal,
trapezioscaphoid, trapeziotrapezoid, and trapezium-second
metacarpal joints, singly or in combination. - Associated unstable, stiff, or painful distal joints of thumb or
swan neck deformity |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL Trapezium Prosthesis and its
predicate devices have a similar design, and are made of the
similar materials. |
| Conclusion | The EXTREMITY MEDICAL Trapezium Prosthesis is
substantially equivalent to its predicate devices. This
conclusion is based upon the fact that this device is substantially
equivalent in terms of indications for use, materials, design and
principles of operation. |
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2/2 K042548
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 in flight, composed of three curved lines above three wavy lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 1 5 2009
EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway Suite 410 Parsippany, NJ 07054
Re: K092548
Trade/Device Name: Extremity Medical Trapezium Prosthesis Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: K.YI Dated: November 19, 2009 Received: November 23, 2009
Dear Mr. Gannoe:
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 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); 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.
3
Page 2 – Mr. Jamy Gannoe
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Jonita Js
Image /page/3/Picture/5 description: This image contains a handwritten symbol that appears to be a combination of a lowercase letter 'g' and a superscript 'n'. The 'g' is written in a cursive style, with a loop at the top and a tail extending downwards. The 'n' is smaller and positioned above and to the right of the 'g', indicating it may be a superscript or an abbreviation. The symbol is presented in black against a white background.
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
510(k) Number (if known): KO925 48
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS Device Name: Indications for Use:
The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:
- Localized pain and palpable crepitation at the base of the thumb on the "grind test" -(circumduction with axial compression of the thumb)
- -Decreased motion, pinch, and grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
- Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity
Over-the-counter Prescription Use X_ AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anita for MXM
Division Signoff
hopedic. iroical estorative Devi
510(k) Number K092578