(240 days)
Not Found
No
The device description and intended use are solely focused on mechanical bone plates, screws, and washers for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to treat fractures and osteotomies, which is a therapeutic purpose.
No
The description states the devices are "intended to treat fractures and osteotomies," which indicates a therapeutic rather than diagnostic purpose.
No
The device description clearly states that the device consists of bone plates, screws, and washers made of Titanium or stainless steel, which are physical hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating fractures and osteotomies of various bones. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details bone plates, screws, and washers made of titanium or stainless steel, designed for physical fixation of bones. This is a mechanical device used within the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, NDG
Device Description
IFS bone plates consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of Titanium 6Al-4V ELI or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052614, K020401, K092493, K063049, K090047, K071264, K072083, K081546, K082527, K052483
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo for Internal Fixation Systems (IFS). The logo consists of a circle with a stylized design inside, followed by the letters "IFS" in bold, sans-serif font. Below the circle and letters, the words "Internal Fixation Systems" are written in a smaller, sans-serif font.
Image /page/0/Picture/1 description: The image contains handwritten text that reads "K110086 # 1/2". The text appears to be a combination of alphanumeric characters and symbols. The number sign is present, followed by a fraction of one-half.
SEP - 9 2011
Internal Fixation Systems, Inc. 510(k) Summary
.
| Company Name: | Internal Fixation Systems, Inc.
10100 N.W. 116th Way, Suite 18
Miami, Florida 33178 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Christopher Endara
10100 N.W. 116th Way, Suite 18
Miami, Florida 33178
(305) 884-5993 |
| Date Prepared: | August 12, 2011 |
| Trade Name: | IFS Bone Plates, Screws, and Washers |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone
Washer |
| Classification: | 21 CFR 888.3030: Single/multiple component metallic bone fixation
appliances and accessories (HRS and NDG)
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
(HWC) |
| Predicate Devices: | Arthrex Low Profile Plate and Screw System (K052614)Synthes Calcaneal Plate (K020401)GPC Medical Bone Plates and Screws (K092493)Synthes USA Modular Mini Fragment LCP System (K063049)Synthes USA 1.5 Mini Fragment LCP System (K090047)Synthes USA 2.4/2.7 Locking Foot Module (K071264)Depuy Orthopaedics Small Fragment Locking Plating System (K072083)Depuy Orthopaedics Small Bone Locking Plate System (K081546)Zimmer Inc. Universal Locking System 3.5mm Plates and Screws (K082527)Synthes Spherical Washers (K052483) |
| Device Description: | IFS bone plates consists of various shapes as well as screws are intended to
treat fractures and osteotomies of various bones, including the clavicle,
pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers
are to function with screws to prevent the screw head from breaking
through the cortex of the bone by providing additional surface area during
screw placement. The plates, screws, and washers are a one-piece device
made of Titanium 6Al-4V ELI or stainless steel. |
1
K110086=2
Image /page/1/Picture/1 description: The image shows a logo with the letters "IFS" in bold, black font. To the left of the letters is a circular graphic with a black and white design. Below the letters is the text "Internal Fixation Systems" in a smaller font. The logo appears to be for a company or organization related to internal fixation systems.
Intended Use: IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments. Substantial Equivalence: IFS bone plates, screws, and washers have the same intended use, same technological characteristics, and materials as the predicate devices. Based on the information submitted, it is determined that the bone plate and screw system is substantially equivalent to the currently marketed predicate devices. Technological Characteristics The IFS bone plates, screws, and washers are substantially equivalent to the Comparison: predicate devices with respect to the design, function, and material. The plates have the same number of holes, similar thickness, lengths, widths, and material composition. The screws have the same diameters, lengths, and material composition. The washers have the same outer diameter, inner diameter, thickness, and material composition. Sterilization Information: The IFS Bone Plates, Screws, and Washers will be distributed non-sterile. The devices are sterilized by the end user per the AAMI Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 106. There are no significant differences between the IFS bone plates, screws, Conclusion: and washers and the other implants as listed in the Substantially Equivalent Devices. The IFS plates, screws, and washers and the predicate devices have similar design attributes, material, and intended use thus is considered substantially equivalent.
2
Image /page/2/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 three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Internal Fixation Systems, Inc. % Mr. Christopher Endara 10100 N.W. 116" Way. Suite 18 Miami, Florida 33178
2011
Re: K110086
Trade/Device Name: IFS Profile Plates, Screws, and Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC. NDG Dated: August 19, 2011 Received: August 30, 2011
Dear Mr. Endara:
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. Insting 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
3
Page 2 – Mr. Christopher Endara
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.
ff 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/wcm115809.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/Industrv/default.htm.
Sincerely vours
Mark A. Wilkinson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K110086
Device Name: IFS Bone Plates, Screws, and Washers
Indications for Use: IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.
The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar M. Muker
(Division Sig (Division Sign-Oil, Orthopedic, Orthopedic, Division of Such and Restorative Devices
Page 1 of
(k) Number K110086
510(k) Number