SHOULDER FIXATION SYSTEM by HAND INNOVATIONS, LLC.

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.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device called the "Modified Shoulder Fixation System." It details administrative information such as the device name, predicate device, classification, indications for use, and a general description of the system. It also includes a letter from the FDA confirming substantial equivalence to a predicate device.

Specifically, the document does not include:

A table of acceptance criteria or reported device performance.
Details about sample sizes, data provenance, or study design for testing.
Information on experts, ground truth establishment, or adjudication methods.
Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Information about training sets or how ground truth for training was established.

Instead, the summary states: "The Modified Shoulder Fixation System is substantially equivalent to the predicate Shoulder Fixation System. The equivalence was confirmed through pre-clinical testing." This implies that the basis for approval was a demonstration of substantial equivalence to an already legally marketed device, often involving comparison of design, materials, and potentially certain mechanical tests, rather than clinical performance studies against specific acceptance criteria.

Summary

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K060290 p.1/1

FEB 2 7 2006

510(k) Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Modified Shoulder Fixation System	Plate Fixation Bone
Name ofPredicateDevices	The device is substantially equivalent to:Shoulder Fixation System (510(k) # K051728 – July 20, 2005) – HandInnovations, LLC.
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act.
Indications forUse	The Modified Shoulder Fixation System is intended for fractures and fracturedislocations, osteotomies, and non-unions of the proximal Humerus.
DeviceDescription	The Modified Shoulder Fixation System is a set of orthopedic plates and fastenerssupplied in a sterilization tray together with several reusable and disposable tools.The set of orthopedic plates and fasteners provided in the sterilization tray consists ofthe 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 andinstruments do not require biocompatibility testing because the stainless steel used infabrications meets the requirements of ASTM F 138-03.
Summary ofSubstantialEquivalence	The Modified Shoulder Fixation System is substantially equivalent to the predicateShoulder Fixation System. The equivalence was confirmed through pre-clinicaltesting.

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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

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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

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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

Regulation Number and Section

§ 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.