(117 days)
No
The device description and performance studies focus on mechanical properties and comparisons to existing plate and screw systems, with no mention of AI or ML.
Yes
The device is indicated for fixation of fractures, mal-unions, nonunions, or osteotomies, which are conditions that require treatment to restore function, making it a therapeutic device.
No
Explanation: The device is a system of plates and screws for fixation of fractures, mal-unions, non-unions, or osteotomies. It is used for treatment, not for diagnosing a condition.
No
The device description explicitly states that the system consists of titanium plates, bone screws, and instruments for implantation, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, mal-unions, nonunions or osteolomies" in various anatomical locations. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details plates, screws, and instruments for implantation. These are physical implants and surgical tools, not reagents, analyzers, or other components typically associated with IVDs.
- Lack of IVD Characteristics: The document does not mention any of the key 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
This device is a surgical implant system used to stabilize bones.
N/A
Intended Use / Indications for Use
The OIC Variable Ande Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteolomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Product codes
HRS, HWC
Device Description
The OIC Variable Ande Small Fragment Locking Plate System consists of titanium plates for the Distal Radius. Clavice. Proximal Humerus, Tibia and Distal Fibula, bone screws and instruments for implantation. The platety of sizes and are pre-contoured to match the anatomy of the patient and 3.5mm bone screws. The bone screws are available in two diameters (2.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.
The OIC Variable Angle Small Fragment Locking Plate System implants are made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.
The devices conform to the following standards:
- ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
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 screws, the plates, the locking interfaces and the behavior of the OIC Variable Angle Small Fragment Locking Plate System were evaluated using finite element stress/strain analyses (FEA). The screws, the plates and the plate-screw constructs were found to have acceptable mechanical characteristics for the intended uses. Similarly, each screw design, plate design and each locked screw-plate sub-construct was found to have similar mechanical performance compared to similar devices used for the same indications as identified via a literature review.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001170, K033669, K050646, K051735, K061352, K071184, K071563, K071715, K080522, K083032, K123832
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
K140357 - page 1 of 2
510(k) Summarv
Prepared 06/03/2014
Name and Address of Manufacturer
The Orthopaedic Implant Company (OIC) 316 California Ave #701 Reno, NV 89509
Contact
Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification
Trade Name: OIC Variable Angle Small Fragment Locking Plate System Common Name: Plate, fixation, bone Screw, fixation, bone Classification Name: Single/Multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Classification: Class II, 21 CFR 888.3030, 888.3040 Panel: Orthopedic Product Code: HRS, HWC
Indications for Use
The OIC Variable Ande Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteolomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Device Description
The OIC Variable Ande Small Fragment Locking Plate System consists of titanium plates for the Distal Radius. Clavice. Proximal Humerus, Tibia and Distal Fibula, bone screws and instruments for implantation. The platety of sizes and are pre-contoured to match the anatomy of the patient and 3.5mm bone screws. The bone screws are available in two diameters (2.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.
The OIC Variable Angle Small Fragment Locking Plate System implants are made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.
The devices conform to the following standards:
- ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.
1
Substantial Equivalence
. 1
Predicate devices: K001170 Synthes 2.7mm LC-DCP, 3.5mm Profile (Limited Contact - Dynamic Compression Plate) K033669 Smith & Nephew Locking Bone Plate System K050646 Synthes (USA) 3.5 / 4.5mm LCP Medial Proximal Tibia Plates K051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity K061352 Peri-Loc Periaticular Locked Plating System - Locking Bone Plates & Screws for the Upper Extremity K071184 Synthes Variable Angle - Locking Compression Plate (VA-LCP) Distal Radius System K071563 Peri-Loc Periarticular Locked Plating System - VLP Locking Bone Plates & Screws K071715 Acumed Congruent Bone Plate System K080522 Synthes 3.5mm LCP Distal Tibia T Plates K083032 PERI-LOC Bone Plating and Screw System K123832 OlC Distal Radius Plating System, OlC Proximal Humerus Plating System, OlC Clavicle Plating System
The new device is substantially equivalent to the predicate devices in regards to intended use, materials, and function. There are no significant differences between the OIC Variable Angle Small Fragment Locking Plate System and the predicate devices listed above. Any minor differences have no effect on safety and effectiveness.
The screws, the plates, the locking interfaces and the behavior of the OIC Variable Angle Small Fragment Locking Plate System were evaluated using finite element stress/strain analyses (FEA). The screws, the plates and the plate-screw constructs were found to have acceptable mechanical characteristics for the intended uses. Similarly, each screw design, plate design and each locked screw-plate sub-construct was found to have similar mechanical performance compared to similar devices used for the same indications as identified via a literature review.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2014
The Orthopaedic Implant Company Mr. Douglas Fulton Quality Assurance Manager 316 California Avenue, Suite 701 Reno, Nevada 89509
Re: K140357
Trade/Device Name: OIC Variable Angle Small Fragment Locking Plate System 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 Dated: May 19, 2014 Received: May 21, 2014
Dear Mr. Fulton:
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 enclosurc) 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 1 ou may, anteres 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 or any . 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
3
Page 2 - Mr. Douglas Fulton
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 contact the Division of Industry and Consumer Education at its toll-free 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" (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/ReportalProblem/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 Industry and Consumer Education 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,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140357
Device Name
OIC Variable Angle Small Fragment Locking Plate System
Indications for Use (Describe)
The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metalarsal.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth 詞腳ank -S
Division of Orthopedic Devices
FORM FDA 3881 (1/14)
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