RETROGRADE ROD SYSTEM by HOWMEDICA CORP.

The Alta® IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.

Device Description

This submission is a modification of the currently marketed Alta IM rods and cap screws cleared under various 510(k) notifications. The new femoral IM rods will have proximal and distal holes for dynamic or static locking. There will also be a dynamic slot design for dynamic locking. They will be available in various configurations including round and fluted designs, solid or cannulated rods in diameters ranging from 9mm to 14 mm in various lengths. A new cap screw will be available with extended ends. These new components will be used with cross-locking screws and other rod components previously cleared under different premarket notifications.

AI/ML Overview

This document appears to be a 510(k) summary and an FDA clearance letter for a medical device, specifically the ALTA® A-P Rod Modification (Retrograde Rod System) for intramedullary nailing of femoral, tibial, and humeral fractures.

Based on the provided text, there is no acceptance criteria or study data present that describes performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance. This type of information is not typically included in a 510(k) summary for a device seeking substantial equivalence based on predicate devices.

The 510(k) process for this type of device (intramedullary fixation rods) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, materials, design, and operational principles, rather than presenting new clinical performance data from a specific study against a set of acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, expert qualifications, or ground truth methods from the provided text.

The closest relevant information is:

Intended Use: Stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur.
Substantial Equivalence: Based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Alta® IM Rod System, Synthes' Ti DFN System, and ACE Medical's ART™ Femoral Nail System.

If this were a submission for a device requiring performance data (e.g., a software as a medical device or a novel diagnostic), this information would be explicitly detailed. However, for this type of hardware modification, the focus is on demonstrating that the new modification does not raise new questions of safety or effectiveness compared to legally marketed predicate devices.

Summary

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SEP 1 4 1998

K982602

510(k) Summary

Proprietary Name: Common Name: Classification Name & Reference: Regulatory Class: Device Product Code: Retrograde Rod System IM Rod Intramedullary Fixation Rod 21 CFR 888.3020 ー 87HSB

For information contact:

Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870

Date prepared:

July 24, 1998

The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Alta® IM Rod System, Synthes' Ti DFN System, and ACE Medical's ART™ Femoral Nail System.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K982602 Trade Name: ALTA® A-P Rod Modification Requlatory Class: II Product Code: HSB July 24, 1998 Dated: Received: July 27, 1998

Dear Ms. Kelly:

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, Druq, and Cosmetic Act (Act). 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 aqainst 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. ਸ਼ੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 requlations.

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Page 2 - Ms. Vivian Kelly

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,

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ALTA® A-P ROD MODIFICATION

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 (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982602

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.