(94 days)
Not Found
No
The device description and intended use are purely mechanical in nature, and there is no mention of AI or ML in the provided text.
Yes
The device, a fracture system used for fragment fixation and osteotomies, is designed to treat fractures and non-unions, which falls under the definition of a therapeutic device.
No
The device is a system of plates and screws intended for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components like plates, screws, and washers made from Ti-6Al-4V, indicating it is a hardware device.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The AFT™ Greater Tuberosity Fracture System is a system of plates and screws designed for the mechanical fixation of bone fractures. It is implanted directly into the body to stabilize broken bones.
- Intended Use: The intended use clearly states "fracture fixation of long bones and long bone fragments" and "fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus." This describes a surgical intervention, not a diagnostic test performed on a sample.
The device's function is to provide structural support to bone, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, long bone fragments, proximal humerus
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)
Geometric equivalence and engineering rationale is provided to demonstrate substantial equivalence.
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.
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.
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8. 510(k) Summary
MAR - 3 2014 K133668
1. Applicant
Shoulder Options, Inc. 100 E. South Main St. P.O. Box 1458 Waxhaw, NC 28173
Date Prepared: November 26, 2013 Contact Person: John Kapitan, CEO Tel: (704)512-0000
Fax: (704)831-5316 Email: kapitan@shoulderoptions.com
2. Device Name
| Common/Usual Name: | Cannulated Bone Screws and Washers
Plate, Fixation, Bone |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Smooth or threaded metallic bone fixation fastener
Single/multiple component metallic bone fixation appliances
and accessories |
| Trade Name: | AFT™ GTF System |
| Regulation Number: | 888.3040
888.3030 |
| Product Code: | HWC: Screw, Fixation, Bone
HRS: Plate, Fixation, Bone |
| Classification: | II |
| Panel: | Orthopedic |
3. Predicate Devices
The Shoulder Options AFT™ Greater Tuberosity Fracture System is substantially equivalent to the following devices:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K121672 | Shoulder Options AFT Proximal Humerus | |
| Fracture Plate | Shoulder Options | |
| K963172 | Synthes 4.5mm Cannulated Screw | Synthes |
| K052483 | Synthes Spherical Washers | Synthes |
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4. Description of the Device
The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.
5. Indications for Use
The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
6. Summary of Performance Data
Geometric equivalence and engineering rationale is provided to demonstrate substantial equivalence.
7. Safety & Effectiveness
The AFT™ Greater Tuberosity Fracture System is substantially equivalent to the Shoulder Options Proximal Humerus Fracture Plate (K121672) and Synthes 4.5mm Cannulated Screw system (K963172, K052483). The devices have the same "Indications for Use," are available by prescription only, and are provided non-sterile for single-use only. Based on this and the design similarities, it can be concluded that the AFT™ Greater Tuberosity Fracture System is both a safe and effective device and is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2014
Shoulder Options, Inc. Mr. John Kapitan 100 East South Main Street, PO Box 1458 Waxhaw, North Carolina 28173
Re: K133668
Trade/Device Name: AFT TM Greater Tuberosity Fracture 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: December 23, 2013 Received: January 8, 2014
Dear Mr. Kapitan:
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
3
Page 2 - Mr. John Kapitan
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 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Vincen Devlin -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Indications for Use Statement
510(k) Number (if known): _K133668
Device Name: AFT™ Greater Tuberosity Fracture System
Indications for Use:
The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices