(25 days)
None
No
The summary describes a mechanical implant system with no mention of software, algorithms, or any terms related to AI/ML.
No
The device is a system of plates used for surgical fixation of fractures, which is a structural support and not a therapeutic function in itself.
No
This device is a surgical implant (plate system) used for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "anatomically contoured, stainless steel and titanium plates," 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 describes the device as a surgical implant used for fixing bone fractures in the distal femur. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical plate and screws made of stainless steel and titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Product codes
JDP, HRS, HWC
Device Description
The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically contoured, stainless steel and titanium plates featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur
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
Mechanical testing was performed comparing the proposed plates to the predicate plates and the results support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K083025, K000066, K041911, K062564, K041533
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 registered trademark symbol to the right of the "S". To the left of the word is a circular logo with a stylized image inside. The logo and the word "SYNTHES" are the main elements of the image.
MAR - 4 2011
KI10354
| 3.0
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes |
| Thomas N. Shea | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6941 | |
| Device Name: | Synthes 4.5mm VA-LCP Curved Condylar Plate System |
| Classification: | Plates: Class II, §888.3030 - Single / multiple component metallic |
| bone fixation appliance and accessories. |
Screws: Class II, §888.3040 - Smooth or threaded metallic bone
fixation fastener. |
| Predicate Devices: | Synthes 4.5mm VA-LCP Curved Condylar Plates (K083025)
Synthes Locking Condylar Plate (LCP) System (K000066)
Synthes LCP Curved Plates (K041911)
Synthes SS/Ti LCP Distal Femur Plate (K062564)
Synthes 4.0/5.0mm Peri-Prosthetic Locking Screws (K041533) |
| Device Description: | The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists
of anatomically contoured, stainless steel and titanium plates
featuring variable angle locking and combi-holes designed to provide
stable fixation of the distal femur. |
| Intended Use: | The Synthes 4.5mm VA-LCP Curved Condylar Plate System is |
Intended im is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Substantial Information presented supports substantial equivalence of the Equivalence: Synthes 4.5mm VA-LCP Curved Condylar Plate System to the predicate device K083025, Synthes 4.5mm VA-LCP Curved Condylar Plates. The proposed plates have the same indications for use, are similar in shape/design and incorporate the same fundamental technology. Mechanical testing was performed comparing the proposed plates to the predicate plates and the results support substantial equivalence.
.... .
. . . .
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. 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. Thomas N. Shea 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K110354
Trade/Device Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: JDP, HRS, HWC Dated: February 04, 2011 Received: February 09, 201-1
MAR - 4 2011
Dear Mr. Shea:
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
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Page 2 – Mr. Thomas N. Shea
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.
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/MedicalDeyices/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,
Aliz B. R. h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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 small "R" in a circle is located to the upper right of the word "SYNTHES".
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes 4.5mm VA-LCP Curved Condylar Plate System
Indications for Use:
The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing mutifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
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 PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mckennon
(Division Sign-Off)
Div.sion of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110354