(316 days)
KII0086, K052483
Not Found
No
The summary describes a mechanical device (bone plates, screws, and washers) made of stainless steel for internal fixation. There is no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is used for internal fixation of bone fractures, fusions, or osteotomies, which directly treats a medical condition.
No
The device is described as a system of plates, screws, and washers for internal fixation of bone fractures, fusions, or osteotomies. Its intended use is for treatment and fixation, not for diagnosis.
No
The device description clearly states it is a system of bone plates, screws, and washers made of stainless steel, which are physical 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a system of bone plates, screws, and washers made of stainless steel. These are physical implants used for internal fixation of bone fractures, fusions, or osteotomies.
- Intended Use: The intended use is for the surgical repair and stabilization of bones within the body.
The Core Orthopaedics bone plates and screws system is a surgical implant used directly on the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Core Orthopaedics bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle. scapula. pelvis. long bone (such as humerus. ulna. radius. femur. tibia, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS, HTN
Device Description
The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones. including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals 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 stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula), and small bones (such as metacarpals, metatarsals, phalanges), acetabulum
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)
The Bone Fragment Fixation Plates Screws and Washers are substantially equivalent to the predicate devices with respect to design and material and dimensional comparison.
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.
KII0086, 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
JAN 17 2014
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Bone Fragment Fixation Plates and Screws device is provided below.
Device Common Name: Plate, Fixation, Bone Screw, Fixation, Bone Washer
Device Proprietary Name: Bone Fragment Fixation Plates, Screws and Washers
- Submitter: Laura Cattabriga 7430 Center Bay Drive N. Bay Village. Florida 33141
Contact:
Laura Cattabriga 7430 Center Bay Drive N. Bay Village, Florida 33141 email: Laurac@core-orthopaedics.com
Classification
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulation: (HWC)
21 CFR 888.3030: Single / multiple component metallic bone fixation appliances and accessories (HRS. HTN)
Panel: Orthopedics
HWC, HRS, HTN Product Code:
Indication for Use: The Core Orthopaedics bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle. scapula. pelvis. long bone (such as humerus. ulna. radius. femur. tibia. and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
Device Description: The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones. including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with
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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 stainless steel.
Performance Data: The Bone Fragment Fixation Plates Screws and Washers are substantially equivalent to the predicate devices with respect to design and material and dimensional comparison.
Substantial Equivalence:
- Internal Fixation Systems. Inc. Bone Plates Screws and Washers . (KII0086)
- Synthes Spherical Washers (K052483) .
Technological Characteristics Comparison: The Bone Fragments Fixations Plates and Screws are equivalent to the predicate devices with respect to design. material and dimensional comparison.
Sterilization Information: The Bone Fragment Fixations Plates and Screws will be distribute 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 10-6.
Conclusion: There are no significant differences between the Bone Fragment Fixations Plates and Screws and the other implants as listed in the Substantially Equivalence Devices. The Bone Fragment Fixations Plates and Screws and the predicate devices have similar design attributes, materials, and intended use thus is substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that represents human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 17, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Laura H. Cattabriga Chief Operating Officer / Chief Financial Officer 7430 Center Bay Drive Miami, Florida 33143
Re: K130614 Trade/Device Name: Bone Fragment Fixation Plates and Screws 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, HTN Dated: December 17, 2013 Received: December 18, 2013
Dear Ms. Cattabriga:
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
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Page 2 - Ms. Laura H. Cattabriga
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vour 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 yours.
Mark Nijhelkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification
Bone Fragment Fixation
Plates, Screws and Washers
Indications for Use Statement
510(k) Number (if known): K130614
Device Name: Bone Fragment Fixation Plates and Screws
Indications For Use:
י
The Core Orthopaedics bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Elizabeth L. Frank -S
Division of Orthopedic Devices