(63 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant (bone plate) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as a plate used for stable fixation of bones, primarily for fractures, osteotomies, and non-unions, which are structural repair functions rather than direct therapeutic treatment of a disease or condition.
No
Explanation: The device is a surgical plate used for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly describes physical plates made of titanium or stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fractures, osteotomies, and non-unions of the radius and other small bones." This describes a surgical implant used to fix bones, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a metal plate and screws designed for surgical implantation. This is consistent with a medical device used in surgery, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on laboratory tests
Therefore, the Synthes LCP Dia-Meta Volar Distal Radius Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Product codes
HRS
Device Description
The Synthes LCP Dia-Meta Volar Distal Radius Plates provide stable fixation for radius fractures. The plates have threaded locking holes in the head of the plate that accept 2.4 mm locking screws, and dynamic compression holes combined with locking holes in the shaft of the plate which accept 3.5 mm cortex, 3.5 mm locking, or 4.0 mm cancellous screws. The plates are available in various lengths and are available in right and left versions to accommodate varying patient anatomy. The plates are manufactured in either titanium or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius and other small bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Synthes Locking Distal Radius Plating System, Synthes Small Fragment Dynamic Compression Locking System
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a registered trademark symbol to the right of the word.
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:
K07D946 (page 1/1)
| 510(k) Summary | Page 1 of 1 | |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6940 | JUN - 6 2007 | |
| Contact: | Sheri L. Musgnung | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6940 | ||
| Device Name: | Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal | |
| Radius Plate | ||
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone | |
| fixation appliances and accessories | ||
| Predicate Device: | Synthes Locking Distal Radius Plating System | |
| Synthes Small Fragment Dynamic Compression Locking System | ||
| Device Description: | The Synthes LCP Dia-Meta Volar Distal Radius Plates provide | |
| stable fixation for radius fractures. The plates have threaded | ||
| locking holes in the head of the plate that accept 2.4 mm locking | ||
| screws, and dynamic compression holes combined with locking | ||
| holes in the shaft of the plate which accept 3.5 mm cortex, 3.5 mm | ||
| locking, or 4.0 mm cancellous screws. The plates are available in | ||
| various lengths and are available in right and left versions to | ||
| accommodate varying patient anatomy. The plates are | ||
| manufactured in either titanium or stainless steel. | ||
| Intended Use: | Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for | |
| fractures, osteotomies, and non-unions of the radius and other | ||
| small bones. | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L Musgnung Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K070946
Trade/Device Name: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plate Regulation Number: 21 CFR 888. 3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 3, 2007 Received: April 4, 2007
Dear Ms. Musgnung:
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
JUN -6 2007
2
Page 2 - Ms. Sheri L Musgnung
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fontarebrent
Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs beneath the word. The "R" in "SYNTHES" has a registered trademark symbol next to it.
Indications for Use
4070946
510(k) Number (if known):
Device Name:
Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates
Indications for Use:
Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Prescription Use _ X (Per 21 CFR 801.109)
. AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Verlane Brechd for war
(Division Sign-( Division of General, Restorative, and Neurological Devices
510(k) Number K070946
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