(21 days)
Not Found
No
The device description and intended use clearly describe a mechanical orthopedic fixation system with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is an orthopedic fixation system (plates, nails, screws, pegs) used for stabilizing fractures and non-unions, which are restorative mechanical functions rather than therapeutic in the medical sense (e.g., drug delivery, disease treatment).
No
Explanation: The device is an orthopedic fixation system (plates and fasteners) used for treating fractures and non-unions, not for diagnosing them. It is explicitly described as an implantable device for treatment, not diagnostic purposes.
No
The device description explicitly states it is a "set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus." This describes a surgical intervention on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device consists of "orthopedic plates and fasteners" and "surgical tools." These are physical implants and instruments used in surgery, not reagents, kits, or instruments for analyzing biological samples.
- Anatomical Site: The anatomical site is the "proximal Humerus," which is a part of the human skeleton. IVDs typically analyze biological samples like blood, urine, tissue, etc.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
Product codes (comma separated list FDA assigned to the subject device)
LXT
Device Description
The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Shoulder Plates Shoulder Nail Plates Multidirectional and 90° Lock Screws 90° Set Screws Pegs Included in the sterilization tray are the following re-useable instruments: Peg drivers Other standard surgical tools.
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)
The equivalence was confirmed through pre-clinical testing.
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.
0
K060290 p.1/1
FEB 2 7 2006
510(k) Summary of Safety and Effectiveness
| General
| Provisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Modified Shoulder Fixation System | Plate Fixation Bone | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| Shoulder Fixation System (510(k) # K051728 – July 20, 2005) – Hand | ||
| Innovations, LLC. | ||
| Classification | Class II. | |
| Performance | ||
| Standards | Performance standards have not been established by the FDA under section 514 of | |
| the Food, Drug and Cosmetic Act. | ||
| Indications for | ||
| Use | The Modified Shoulder Fixation System is intended for fractures and fracture | |
| dislocations, osteotomies, and non-unions of the proximal Humerus. | ||
| Device | ||
| Description | The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners | |
| supplied in a sterilization tray together with several reusable and disposable tools. | ||
| The set of orthopedic plates and fasteners provided in the sterilization tray consists of | ||
| the following implantable devices: | ||
| Shoulder Plates Shoulder Nail Plates Multidirectional and 90° Lock Screws 90° Set Screws Pegs Included in the sterilization tray are the following re-useable instruments: Peg drivers Other standard surgical tools. | ||
| Biocompati- | ||
| bility | The implantable components of the Modified Shoulder Fixation System and | |
| instruments do not require biocompatibility testing because the stainless steel used in | ||
| fabrications meets the requirements of ASTM F 138-03. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | The Modified Shoulder Fixation System is substantially equivalent to the predicate | |
| Shoulder Fixation System. The equivalence was confirmed through pre-clinical | ||
| testing. |
1
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health and Human Services (HHS) in the USA. The seal features the HHS logo, which is a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2006
Hand Innovations, LLC. C/O Mr. Ernesto Hernandez 8905 SW 87th. Avenue Suite 220 Miami, Florida 33176
Re: K060290
Trade/Device Name: Shoulder fixation system Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT Dated: February 1, 2006 Received: February 7, 2006
Dear Mr. Hernandez:
We have reviewed your Section 510(k) premarket notification of intent to market the device t we have te vice your Section of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the theresure) to regary to regars and the Medical Device American be and Food. Drya commence pro- 10 May 20, 1978, the enaonance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Rec) that do not require subject to the general controls provisions of the Act. The You may, merciole, market the device, books of the more of the may begineration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soo above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contributi may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Pouchas concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA s issuated of a baceaan.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any recetal statutes and regulations annuding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 – Mr. Ernesto Hernandez
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Doctoris of 1 - vice as described in your Section 510(k)
This letter will allow you to begin marketing your device for a force for a log I his letter will anow you to ocgin maketing of substantial equivalence of your device to a legally premarket notheadon. The PDA midning of backanding of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your dones at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Complanoo at (210) = 16 or 807.97). You may obtain Misorallung by icrerchee to promaxionshibilities under the Act from the Division of Small other general Information on your responsible the toll-free number (800) 638-204) or and Manufacturers, International and Consulter Fishbusters and concern/industry/support/index.html.
Sincerely yours,
Heber Leena
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kolo 1290
510(k) Number (if known):
Device Name: Shoulder Fixation System
Indications for Use Statement
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | √ |
|---|---|
| OR Over-The-Counter Use ______ |
(Division Signature)
Division of General, Restorative,
and Neurological Devices
Modified Shoulder Fixation System Special 510(k) January 27, 2006