The Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

Device Description

The Aequalis Humeral Nail System includes intramedullary nails and screws. The Aequalis Humeral Nail is a straight, cannulated intramedullary nail with a 9mm proximal diameter and a distal diameter that tapers from 8mm to 5mm. It is 130mm long and is available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the nail incorporates one slot and one screw hole for distal locking using 4.5mm screws. The nail and screws are manufactured from anodized Ti-6Al-4V alloy.

AI/ML Overview

This document is a 510(k) summary for a medical device (Aequalis Humeral Nail System) seeking market clearance, not a study report detailing performance against acceptance criteria. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics is not present in the provided text.

Specifically, the document:

Describes the device (Aequalis Humeral Nail System) and its intended use.
Compares it to predicate devices to demonstrate substantial equivalence, based on similarities in indications for use, design, materials, and "results of stress calculations."
Contains the FDA's clearance letter stating that the device is substantially equivalent to legally marketed predicate devices.

There is no experimental study described in this document that would establish acceptance criteria or provide device performance data in the manner requested. The clearance is based on substantial equivalence to existing devices that have already been cleared and are deemed safe and effective.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this device based on the provided text. The "stress calculations" mentioned as a basis for comparison are not further detailed or presented with specific results and acceptance criteria.

Summary

{0}------------------------------------------------

KOB2754 (pg1/2)

TORNI

510(k) Summary

JAN 2 7 2009

510(k) SPONSOR and APPLICANT: Tornier 100 Capital Drive Suite 201 Warsaw IN 46582

CONTACT PERSON:

Brian Hodorek Sr. Development Engineer (574) 268-0861 x 344 BHodorek@Tornier.com

TRADE NAME:

Aequalis Humeral Nail System

Intramedullary Nail

COMMON NAMES:

CLASSIFICATION and CLASS:

PRODUCT CODE:

PREDICATE DEVICES:

· Howmedica Osteonics T2 Proximal Humeral Nail (K042396)
21 CFR 888.3020 - Intramedullary Fixation Rod, Class II

87 HSB - Intramedullary Fixation Rod and Accessories

· FH Industrie Titanium Telegraph Humeral Nail (K042332)
· Smith & Nephew TriGen Straight Humeral Nail System (K032722)

DEVICE DESCRIPTION:

{1}------------------------------------------------

INDICATIONS:

COMPARISON TO PREDICATES:

The Aequalis Humeral Nail System is substantially equivalent to the predicate devices based on similarities in indications for use, design and materials and the results of stress calculations.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2-7 2009

Tornier % Mr. Brian Hodorek 100 Capital Drive Suite 201 Warsaw, IN 46582

Re: K082754

Trade/Device Name: Aequalis Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: January 19, 2009 Received: January 21, 2009

Dear Mr. Hodorek:

We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave reviewed your becaren on the device is substantially equivalent (for the indications ferenoned above and in sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to May 2011-17-11, 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 I ou may, derenste, manus of the Act include requirements for annual registration, listing of general connois provisions of arctice, 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 (600 as copy ols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be fourther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that 1271 bilsantes or our device complies with other requirements of the Act that FDA has made a decorminations administered by other Federal agencies. You must of any Federal statutes and regulations assimized to: registration and listing (21 Comply with an the Act 3 requirements, as a manufacturing practice requirements as set C.FK Part 607), labeling (21 CFR Part 820); and 1f applicable, the electronic forul in the quality systems (Q5) regular (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mr. Brian Hodorek

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally of 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

KOB2754 (pg 1/1)

Device Name: Aequalis Humeral Nail System

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

082184

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number.

ర్

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.