(73 days)
HRS
Not Found
No
The device description and intended use are purely mechanical, describing a bone plate and its features. There is no mention of software, algorithms, or data processing that would suggest AI/ML.
No
Explanation: This device is an orthopedic implant (plate) used to fix fractures, osteotomies, and non-unions of the distal fibula. While it aids in the healing process, it does not directly treat a disease or condition in the way a therapeutic device for diagnostics, monitoring, or active intervention might. It's a structural support rather than an active therapy.
No
Explanation: The device, Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, is described as being used for fractures, osteotomies, and non-unions, and its description focuses on its physical characteristics and the types of screws it accepts. There is no mention of the device being used to identify or determine the nature of a disease or condition, which would make it a diagnostic device. It appears to be an implant used for treatment.
No
The device description clearly describes physical plates made of stainless steel and titanium, which are hardware components. There is no mention of software as the primary or sole component of the 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 provided text describes a surgical implant (a plate) used to fix fractures and other bone issues in the distal fibula. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for treating fractures, osteotomies, and non-unions of the distal fibula. This is a therapeutic/surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Product codes
HRS
Device Description
Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft. 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm and 3.5 mm locking screws along with 2.4 mm, 2.7 mm and 3.5 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal fibula
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 LCP Plate
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
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. A registered trademark symbol is located to the right of the word.
510(k) Summary
3.0
Page _________ of _____ of __l
Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester. PA 19380 (610) 719-6940 Sheri L. Musgnung Contact: Synthes (USA) 1 2 2 1 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6940 Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Device Name: Class 11, 888.3030 - Single/multiple component metallic bone Classification: fixation appliances and accessories Predicate Device: Synthes One Third Tubular LCP Plate Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to Device Description: match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft. 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm and 3.5 mm locking screws along with 2.4 mm, 2.7 mm and 3.5 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths. Intended Use: The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Substantial Information presented supports substantial equivalence. Equivalence:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle.
FEB 21 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri Musgnung 1301 Goshen Parkway West Chester, PA 19380
Re: K073460 Trade/Device Name: Synthes 2.7 mm/3.5 mm LCP Distal Fibula 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: December 6, 2008 Received: December 10, 2008
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 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.
2
Page 2 - Ms. Sheri Musgnung
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
u
2.0
Indications for Use
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates |
| Indications for Use: | The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are |
indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGETF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Moreno
Revision Sign-Off
Jivision Sign-Or (Division of General, Restorative, and Neurological Devices
510(k) Number K073466