(27 days)
No
The summary describes a mechanical implant (plate and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for conditions such as post-traumatic arthritis, rheumatoid wrist deformities, and severe unremitting wrist pain, all of which are medical conditions that require treatment. The device aims to provide a clinical benefit by addressing these issues and restoring function or alleviating pain.
No
Explanation: The device is described as an anatomically contoured plate used for wrist arthrodesis and fractures of other small long bones. Its intended use is for surgical intervention (fusion and fixation), not for diagnosing medical conditions.
No
The device description clearly details physical components made of titanium or stainless steel, such as plates and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for surgical implantation to treat bone fractures and deformities in the wrist, clavicle, and olecranon. This is a therapeutic device used directly on the patient's body.
- Device Description: The device is a metal plate and screws designed for internal fixation of bones. This is a surgical implant.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens for diagnostic purposes.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability, post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; turnor resection; and spastic deformities. Single use device for cementless use only.
Product codes
87 LXT
Device Description
These anatomically contoured plates are offered in two lengths (standard or short), manufactured from either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229).
The plate contains a single row of screw holes (2.4mm, 2.7mm and 3.2mm in diameter) down its length. The locking screws are 2.4mm in diameter and vary in length from 6mm to 14mm. The 2.7mm and 3.2mm screws were previously cleared.
In addition to the screws, the device utilizes a press fit intramedullary fixation for the proximal stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, clavicle, olecranon
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
OCT オデ 視聴
Image /page/0/Picture/2 description: The image shows the logo for DVO Extremity Solutions. The letters "DVO" are in large, bold, white font against a black background. Below the letters, the words "Extremity Solutions" are written in a smaller, bold, black font.
,
Solutions 720 E. Winona Ave., Warsaw, IN 46580 877-777-9DVO
510(k) Summary of Safety and Effectiveness
| SUMMARY PREPARED: | September 28, 2005 |
|---|---|
| 510(k) SPONSOR/APPLICANT: | DVO Extremity Solutions, LLC |
| 720 E. Winona Ave., Warsaw, IN 46580 | |
| 510(k) PREPARER and | |
| CONTACT PERSON: | Dina L. Weissman, J.D. |
| P.O. Box 205, Derby CT 06418 | |
| Telephone: (203) 287-0485, Email: DLWeissman@aol.com | |
| TRADE NAME: | Wrist Fusion Plate |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | Class II per 21 CFR § 888.3030 Single/multiple component |
| metallic bone fixation appliances and accessories. | |
| DEVICE PRODUCT CODE: | 87 LXT |
| PREDICATE DEVICES: | Synthes, Wrist Fusion Plates, K000558, cleared 14 April 2000 |
| DEVICE DESCRIPTION: | These anatomically contoured plates are offered in two lengths |
| (standard or short), manufactured from either titanium (ASTM | |
| F-136) or stainless steel (ASTM F-138 or ASTM F-2229). | |
| The plate contains a single row of screw holes (2.4mm, 2.7mm | |
| and 3.2mm in diameter) down its length. The locking screws are | |
| 2.4mm in diameter and vary in length from 6mm to 14mm. The | |
| 2.7mm and 3.2mm screws were previously cleared. | |
| In addition to the screws, the device utilizes a press fit | |
| intramedullary fixation for the proximal stem. | |
| INTENDED USE: | For wrist arthrodesis and for fractures of other small long bones |
| such as the clavicle and olecranon. Specific indications include | |
| post-traumatic arthritis of the joints of the wrist; rheumatoid | |
| wrist deformities requiring restoration; complex carpal | |
| instability, post-septic arthritis of the wrist; severe unremitting | |
| wrist pain related to motion; brachial plexus nerve palsies; | |
| turnor resection; and spastic deformities. Single use device for | |
| cementless use only. | |
| COMPARISON TO PREDICATES: | The Wrist Fusion Plate is similar to the listed predicate device in |
| intended use, performance characteristics, materials of | |
| construction, manufacturing methods and design. | |
| Biomechanical comparisons confirm similar mechanical | |
| properties. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement around the symbol. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DVO Extremity Solutions, LLC c/o Dina L. Weissman, J.D. P.O. Box 205 Derby, Connecticut 06418
OCT 2 7 2005
Re: K052754 Trade/Device Name: Wrist Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: September 28, 2005 Received: September 30, 2005
Dear Ms. Weissman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed 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 for tase stated in the energent date of the enactment date of the Medical Device Amendments, or 10 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). and cosmetic Fee , roo, warket the device, subject to the general controls provisions of the Act. The r ou may, atterest 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 n your de roo such additional controls. Existing major regulations affecting your device can be found in the Codc 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 cquivalence 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 CHR 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.
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Page 2 - Dina L. Weissman, J.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will and of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits 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 acrively of Compliance at (240) 276-0120. Also, please note the regulation entitled, Comace the Ories of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Signature
رسم Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KOSZ754 510(k) Number (if known): ___
Device Name: Wrist Fusion Plate
Indications for Use:
For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon Specific indications include post-traumatic arthritis of the joints of the wrist, chevroatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.
This single use device is for cementless use only.
Prescription Use XXXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number Foss 354