(97 days)
Not Found
Not Found
No
The summary describes a metallic plate for bone fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a metallic plate designed to stabilize fractures, which is a therapeutic intervention.
No
Explanation: The device description clearly states "Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis." This describes a surgical implant used for fixation, not a device that identifies or determines the nature of a disease or condition.
No
The device description clearly states it consists of "metallic plates," indicating a hardware component, not a software-only device.
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 description clearly states that the Synthes 3.5mm Quadrilateral Surface Plates are "metallic plates pre-shaped to fit the quadrilateral surface of the pelvis." This describes a physical implant used in surgery.
- Intended Use: The intended use is for "quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates." This describes a surgical procedure to repair bone fractures.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.
Product codes
HRS
Device Description
Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis. The plates are provided in short, standard, and long versions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis
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)
Synthes One-Third Tubular Plates
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, with a circled "@" symbol to the left of the word. To the right of the word "SYNTHES" is the number "K093928" in a handwritten style. There is a black line underneath the word "SYNTHES" and the number "K093928".
| 3.0 | 510(k) Summary | Page | 1 | of | |||
|---|---|---|---|---|---|---|---|
| Sponsor: | Synthes (USA) | ||||||
| Karl J. Nittinger | |||||||
| 1301 Goshen Parkway | |||||||
| West Chester, PA 19380 | |||||||
| (610) 719-6941 | MAR 2 9 2010 | ||||||
| Device Name: | Synthes 3.5mm Quadrilateral Surface Plates | ||||||
| Classification: | Class II, §888.3030 -- Single/multiple component metallic bone | ||||||
| fixation appliances and accessories. | |||||||
| Predicate Device: | Synthes One-Third Tubular Plates | ||||||
| Device Description: | Synthes 3.5mm Quadrilateral Surface Plates consist of metallic | ||||||
| plates pre-shaped to fit the quadrilateral surface of the pelvis. The | |||||||
| plates are provided in short, standard, and long versions | |||||||
| Indications for | |||||||
| Use: | Synthes 3.5mm Quadrilateral Surface Plates are indicated for | ||||||
| quadrilateral surface comminution associated with acetabular | |||||||
| fractures when used in conjunction with Synthes pelvic | |||||||
| reconstruction plates. | |||||||
| Substantial | |||||||
| Equivalence: | Information presented supports substantial equivalence. |
で
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR 2 9 2010
Re: K093928
Trade/Device Name: Synthes 3.5mm Quadrilateral Surface Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 16, 2010 Received: March 19, 2010
Dear Mr. Nittinger:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
2
Page 2 - Mr. Karl J. Nittinger
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Barbara Boychuk
Director Division of Surgical, Orthopedic, and Restorative 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 is located underneath the word. The symbol for a registered trademark is located to the right of the word.
| 2.0 | Indications for Use |
|---|---|
| ----- | --------------------- |
| 510(k) Number (if known): | K093928 |
|---|---|
| Device Name: | Synthes 3.5mm Quadrilateral Surface Plates |
Indications for Use:
Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral
surface comminution associated with acetabular fractures when used in
conjunction with Synthes pelvic reconstruction plates.
| Prescription Use
(Per 21 CFR 801.109) | X | 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)
Jubare Andrus Anym
(Division Sign-Off)
Division of Surgical, Orthopedic, Orthopedic, DWision of Suices
510(k) Number K093928
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