(83 days)
Not Found
KTT, HWC
No
The 510(k) summary describes a system of cannulated screws and a sliding hip screw for fracture fixation. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses solely on the mechanical function and intended use of the orthopedic implants.
No
The device is described as an OIC Cannulated Screw System and an OIC Sliding Hip Screw (SHS) System used for fracture fixation in bones. These are implants designed to provide structural support and aid in the healing of fractures, not to provide therapy in the sense of treating a disease or disorder through non-invasive means or by delivering a therapeutic agent.
No
The document describes the intended use and indications for a cannulated screw system and a sliding hip screw system, both used for fracture fixation. These are surgical implants for treatment, not diagnostic tools that identify or characterize diseases or conditions.
No
The device description is not available, but the intended use clearly describes a "Cannulated Screw System" and a "Sliding Hip Screw (SHS) System," which are physical implants used for fracture fixation. These are hardware devices, not software-only.
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 (cannulated screws and sliding hip screws) used for the fixation of bone fractures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: While the description is "Not Found," the intended use strongly indicates a physical implant.
- No Mention of Diagnostic Activities: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
- Anatomical Site: The anatomical sites listed are related to bones and joints, consistent with orthopedic surgery.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically stabilize bone fractures.
N/A
Intended Use / Indications for Use
- a. OIC Cannulated Screw System is used for adult and pediatric patients as indicated for pelvic, small and longbone fracture fixation. OIC 6.5/7.3mm cannulated screws are indicated for large bones and large bone fragments such as ankle arthodeses, intercondylar femur fractures, pediatric femoral neck fractures (6.5mm cannulated screws only), sacroiliac joint disruptions, and subtalar athrodeses. OIC 4.0mm cannulated screws are indicated for the fracture fixation of small bones and small bone fragments such as metatarsal and phalangeal osteotomies, fractures of the tarsals and metatarsals, tarsometatarsal and metatarsophalangeal athrodeses, osteochondritis dissecans, and other small fragment cancellous bone fractures.
- b. The OIC Sliding Hip Screw (SHS) System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in subtrochanteric, intertrochanteric, and basilar neck fracture. The SHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. The SHS provides controlled collapse and compression of fracture fragments. This results in stable fixation and prevents undue stress concentration on the implant.
Product codes
KTT, HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic, small and longbone (Cannulated Screw System); Ankle, intercondylar femur, pediatric femoral neck, sacroiliac joint, subtalar, metatarsal, phalangeal, tarsals, tarsometatarsal, metatarsophalangeal (Cannulated Screw System); Proximal femur, subtrochanteric, intertrochanteric, basilar neck (Sliding Hip Screw System)
Indicated Patient Age Range
Adult and pediatric patients (Cannulated Screw System)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 2 2012
The Orthopaedic Implant Company % Mr. Kevin Walls Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121
Re: K113123
Trade/Device Name: OIC Cannulated Screw System; OIC Sliding Hip Screw (SHS) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, HWC Dated: October 20th, 2011 Received: October 21th, 2011
Dear Mr. Walls:
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
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Page 2 – Mr. Kevin Walls
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 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/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/Industry/default.htm.
Sincerely yours,
for Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K113123
Device Name:
- a. OIC Cannulated Screw System
- b. OIC Sliding Hip Screw (SHS) System
Indications for Use:
- a. OIC Cannulated Screw System is used for adult and pediatric patients as indicated for pelvic, small and longbone fracture fixation. OIC 6.5/7.3mm cannulated screws are indicated for large bones and large bone fragments such as ankle arthodeses, intercondylar femur fractures, pediatric femoral neck fractures (6.5mm cannulated screws only), sacroiliac joint disruptions, and subtalar athrodeses. OIC 4.0mm cannulated screws are indicated for the fracture fixation of small bones and small bone fragments such as metatarsal and phalangeal osteotomies, fractures of the tarsals and metatarsals, tarsometatarsal and metatarsophalangeal athrodeses, osteochondritis dissecans, and other small fragment cancellous bone fractures.
- b. The OIC Sliding Hip Screw (SHS) System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in subtrochanteric, intertrochanteric, and basilar neck fracture. The SHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. The SHS provides controlled collapse and compression of fracture fragments. This results in stable fixation and prevents undue stress concentration on the implant.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Elizabeth Th
Col Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K113123