The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

Device Description

The Orthopedic Designs, Inc. Ultimate Compression Hip Screw is a cannulated lag screw to be used with a standard side plates for fracture fixation and stabilization of the proximal femur until bony union can occur. ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration. The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary. The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution. A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.

AI/ML Overview

The provided text does not describe an acceptance criteria or a study that proves the device meets acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device: the ODi Ultimate Compression Hip Screw.

This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than establishing and meeting novel performance acceptance criteria through clinical or scientific studies.

Here's a breakdown of why this information is not present in the provided text, and what is included:

Acceptance Criteria and Device Performance: The document states, "No performance standards applicable to the fixation bone screw have been established by the FDA." and "However the 316-L and 22-13-5 stainless steel used to manufacture the ODi Ultimate Compression Hip Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F138-92 and ASTM F1314-95 respectively)." This is the closest it comes to "acceptance criteria," but these are material specifications, not performance criteria for the device itself. There is no reported device performance data in relation to specific acceptance criteria.
Sample Size for Test Set and Data Provenance: No test samples or data provenance are mentioned, as no performance study was conducted.
Number of Experts and Qualifications: Not applicable, as no ground truth establishment through expert review was performed for a performance study.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not conducted or mentioned. The document relies on substantial equivalence.
Standalone Performance (Algorithm only): Not applicable, as this is a mechanical orthopedic device, not an algorithm.
Type of Ground Truth: Not applicable, as no performance study was conducted.
Sample Size for Training Set: Not applicable.
Ground Truth for Training Set: Not applicable.

What the document does provide in relation to regulatory submission is:

Device Description: Details on material, design, function, and available sizes.
Indications for Use: What the device is intended for.
Contra-indications for Use: When the device should not be used.
Predicate Devices: A list of previously cleared devices to which the ODi Ultimate Compression Hip Screw is claimed to be substantially equivalent. This is the core of a 510(k) submission: demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Material Standards: Conformance to ASTM material standards for the stainless steel used.

In summary, this document is a 510(k) summary for a mechanical device, which relies on substantial equivalence to predicate devices rather than independent performance studies to establish unique acceptance criteria and prove their satisfaction.

Summary

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JAN 2 0 1999

K984331

Premarket Notification

510(k) Summary of Safety and Effectiveness Information

For Release Upon Request Only

November 28, 1998 Date of Preparation:

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company Name / Contact:

Company:	ODi (Orthopedic Designs, Inc.)6971 1st Ave. NorthSt. Petersburg, FL 33710
----------	-----------------------------------------------------------------------------------

Contact: Jeff Godsted (727) 343-0338

Establishment Registration Number:	The registration number forOrthopedic Designs, Inc. ispending
Classification Name:	Screw, Fixation, Bone

Classification Reference:	21 CFR § 888.3040
Common Used Name:	Orthopedic Compression Bone Screw
Device Product Code:	HWC
Classification Panel:	888 - Orthopedic Devices
Trade Proprietary Name:	ODi Ultimate Compression Hip Screw

Proposed Regulatory Class:

The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-3040. The product code generally referred to is HWC (Product Code: HWC), and ODi submits this application under this designation.

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Performance Standards:

No performance standards applicable to the fixation bone screw have been established by the FDA. However the 316-L and 22-13-5 stainless steel used to manufacture the ODi Ultimate Compression Hip Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F138-92 and ASTM F1314-95 respectively).

Package and Labeling:

Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion which prevents damage to the container or package.

Device Description:

ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration.

The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment

Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary.

The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution.

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A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.

Indications for Use:

The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures. intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

Contra-indications for Use:

The ODi Ultimate Compression Hip Screw is not intended for use in patients with the following conditions:

1. Active local Infection.
1. Metal sensitivity or allergic reaction to foreign bodies.
1. Other conditions that may place the patient at risk.
1. When quality of bone stock prevents secure seating of the screws.

Substantial Equivalent Devices:

Orthopedic Designs, Inc. believes the ODi Ultimate Compression Hip Screw is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison:

Howmedica Compression Hip Screw System	(K781762)
Howmedica Compression Hip Screw Sideplate	(K823548)
Howmedica Alta Lag Screw & Compression Screw	(K900584)
Howmedica Omega Compression Screw System	(K850886)
	(K872223)
Howmedica Omega+ Compression Hip Screw System	(K955306)
Howmedica Omega Plus Compression Hip System	(K922295)
Synthes DHS Hip Screw	(K791619)

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Substantial Equivalent Devices continued:

Ace Cannulated Hip Screw and Captured Hip Screw System Richards KeyLock System Richards Kwik-Key Richards Ambi Compression Hip Screw Richards Classic Zimmer Compression Hip Screw with ECT Zimmer Free-Lock Zimmer Versa-Fx Orthopedic Equipment Company's (OECO.C.) Compression Hip Screw Plate Wright Hip Compression Screw/Plate Wright Concise Compression Hip Screw System Wright Cannulated Plus Screw System Depuy Combined NoLok /Keyed Compression Hip Screw System (K861178), (K946156)

Each of these products are commercially available and marketed Class II devices indicated for similar use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1999

Mr. Jeff Godsted Vice President of Legal and Regulatory Affairs Orthopedic Designs, Inc. 6971 1st Avenue North 33710 St. Petersburg, Florida

Re: K984331 ODi Ultimate Compression Hip Screw Trade Name: Regulatory Class: II Product Code: HWC Dated: November 27, 1998 Received: December 3, 1998

Dear Mr. Godsted:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jeff Godsted

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

a M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEVICE INDICATIONS FOR USE

Page 1 of 1

510(k) Number: 1984331

Device Name: ODi Ultimate Compression Hip Screw

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (per 21 CFR 801.109) OR

Over-The-Counter

(Optional Format 1-2-96)

signature

aral Restorative De 198433

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.