(65 days)
Not Found
Not Found
No
The summary describes a mechanical orthopedic implant (bone plate and screws) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a femur plate used to treat fractures, non-unions, or malunions, which directly addresses a medical condition or injury.
No
The device is a surgical plate used for fixing bone fractures, not for diagnosing medical conditions.
No
The device description explicitly states the device is a physical plate manufactured from stainless steel and titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are implants made of stainless steel and titanium, designed to be surgically implanted to fix bone fractures.
- Intended Use: The intended use is to treat fractures of the femur by providing mechanical support and fixation. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant used for orthopedic fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are intended for treatment of fractures of the femur including: Basilar neck fractures such as Pauwels Type 3; fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, mutlifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed or transverse or with additional fracture of medial cortex; fractures of the proximal end of the femur combined with ipsilateral shaft fractures, metastatic fractures of the proximal femur; and also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
Product codes
HRS
Device Description
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are contoured to match the anatomy of the proximal femur. The plates feature a limited-contact profile and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 4.5 mm cortex, 5.0 mm locking screws, 5.0 mm cannulated locking screws, 7.3 mm cannulated locking screws, and 7.3 mm cannulated conical screws. The plates are manufactured from stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Femur, 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 (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 LCP Proximal Femur Plate, Synthes 7.3 mm Cannulated Screws
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 a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A horizontal line is present below the word. A registered trademark symbol is located to the right of the word.
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| 3.0 | 510(k) Summary | Page 1 of 1 | |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| 1301 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6940 | MAR 2 8 2007 | ||
| Contact: | Sheri L. Musgnung | ||
| Synthes (USA) | |||
| 1301 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6940 | |||
| Device Name: | Synthes 4.5 mm LCP Posterolateral Proximal Femur Plate | ||
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone | ||
| fixation appliances and accessories | |||
| Predicate Device: | Synthes LCP Proximal Femur Plate | ||
| Synthes 7.3 mm Cannulated Screws | |||
| Device Description: | Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are | ||
| contoured to match the anatomy of the proximal femur. The plates | |||
| feature a limited-contact profile and Combi holes (Dynamic | |||
| Compression Plate holes combined with locking screw holes), | |||
| which accept 4.5 mm cortex, 5.0 mm locking screws, 5.0 mm | |||
| cannulated locking screws, 7.3 mm cannulated locking screws, and | |||
| 7.3 mm cannulated conical screws. The plates are manufactured | |||
| from stainless steel and titanium. | |||
| Intended Use: | Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are | ||
| intended for treatment of fractures of the femur including: Basilar | |||
| neck fractures such as Pauwels Type 3; fractures of the trochanteric | |||
| region, trochanteric simple, cervicotrochanteric, | |||
| trochanterodiaphyseal, mutlifragmentary pertrochanteric, | |||
| intertrochanteric, intertrochanteric reversed or transverse or with | |||
| additional fracture of medial cortex; fractures of the proximal end | |||
| of the femur combined with ipsilateral shaft fractures, metastatic | |||
| fractures of the proximal femur; and also for use in fixation of | |||
| osteopenic bone and fixation of non-unions or malunions. | |||
| Substantial | |||
| Equivalence: | Information presented supports substantial equivalence. |
. .
000005
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR 2 8 2007
· Re: K070208
Trade/Device Name: 4.5mm LCP Posterolateral Proximal Femur Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: January 18, 2007 Received: January 22, 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 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 L. 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 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 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 yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological 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 horizontal line is present below the word "SYNTHES" and the logo. A registered trademark symbol is located to the right of the word.
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates
Indications for Use:
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are intended for treatment of fractures of the femur including:
- Basilar neck fractures such as Pauwels Type 3, .
- . Fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, mutlifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed or transverse or with additional fracture of medial cortex;
- . Fractures of the proximal end of the femur combined with ipsilateral shaft fractures, metastatic fractures of the proximal femur; and
- . Also for use in fixation of osteopenic bone and fixation of non-unions or 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)
currence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number
000004