(117 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a bone plate and screws, with no mention of AI or ML.
No
The device is a fracture plate and screws, which are implantable devices used to stabilize fractures, rather than a device that provides therapy for an illness or condition.
No
This device, a fracture plate, is used for treatment (fixing fractures) rather than diagnosing conditions.
No
The device description clearly states it is a physical plate and screws made of Ti-6Al-4V, intended for surgical implantation. It also mentions performance studies involving bending testing of the physical 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The AFT™ Proximal Humerus Fracture Plate is a physical implant designed to fix fractures in the proximal humerus bone. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is to treat fractures and related conditions of the proximal humerus, not to diagnose a condition based on in vitro testing.
The information provided clearly describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The AFT™ Proximal Humerus 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)
HRS, HWC
Device Description
The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Testing of the AFT™ Proximal Humerus Fracture Plate to demonstrate substantial equivalence included static and dynamic bending testing per ASTM F382-99.
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.
K041860, K011815, K963172, K042695
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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OCT
8. 510(k) Summary
Shoulder Options, Inc. 100 E. South Main St. P.O. Box 1458 Waxhaw, NC 28173
June 5, 2012 Date Prepared: John Kapitan, CEO Contact Person: Tel: (704)512-0000
Fax: (704)831-5316 Email: kapitan@shoulderoptions.com
2. Device Name
| Common/Usual Name: | Plate, Fixation, Bone |
|---|---|
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories |
| Regulation Number: | 888.3030 |
| Product Code: | HRS, HWC |
| Classification: | II |
| Panel: | Orthopedic |
3. Predicate Devices
The Shoulder Options AFT™ Proximal Humerus Fracture Plate is substantially equivalent to the following devices:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K041860 | Synthes LCP Proximal Humerus Plate | Synthes |
| K011815 | Synthes LCP Proximal Humerus Plate | Synthes |
| K963172 | Synthes 4.5mm Non-Locking Cannulated | |
| Screw | Synthes | |
| K042695 | 4.5mm NCB Proximal Humerus Non- | |
| Locking Screw | Zimmer |
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4. Description of the Device
The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.
5. Indications for Use
The AFT™ Proximal Humerus 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
Testing of the AFT™ Proximal Humerus Fracture Plate to demonstrate substantial equivalence included static and dynamic bending testing per ASTM F382-99.
7. Safety & Effectiveness
The AFT™ Proximal Humerus Fracture Plate is substantially equivalent to the Synthes LCP Proximal Humerus Fracture Plate (K041860, K011815), Synthes 4.5mm Non-Locking Cannulated Screw ( K963172), and Zimmer NCB Proximal Humerus Non-Locking Screw (K042695). 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™ Proximal Humerus Fracture Plate is both a safe and effective device and is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
קומא א
Shoulder Options, Incorporated
% Mr. John Kapitan
CEO
100 East South Main Street
P.O. Box 1458
Waxhaw, North Carolina 28173
Re: K121672
Trade/Device Name: AFT" Proximal Humerus Fracture Plate 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: August 15, 2012 Received: August 20, 2012
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
3
Page 2 - Mr. John Kapitan
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,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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): K121672
Device Name: AFT™ Proximal Humerus Fracture Plate
Indications for Use:
The AFT™ Proximal Humerus 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 (Part 21 CFR 801 Subpart D) (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)
Aht
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K121672 510(k) Number