The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.

The Clinical Indication for Use is:

"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."

Device Description

The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.

Modular bistemmed intramedullary rod system with rigid cam locking mechanism designed to provide intraoperative adjustment after cementing components into the proximal and distal segments of the resected humerus.

Materials: Ti-6Al-4V NiTi alloy (locking system)

AI/ML Overview

The provided text describes a 510(k) summary for a "Segmental Defect Replacement System." This document is a premarket notification for a medical device aiming to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the specific information requested regarding acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not present in the provided text.

The document focuses on comparing the proposed device to existing predicate devices based on:

Intended Use: Reconstruction of the humeral diaphysis with extensive bone lesions due to metastatic disease, myeloma, or lymphoma, placing the humerus at risk for pathologic fracture.
Design: Modular bistemmed intramedullary rod system with a rigid cam locking mechanism for intraoperative adjustment after cementing components.
Materials: Ti-6Al-4V, NiTi alloy (locking system).

The document states: "The Segmental Defect Replacement System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices." However, it does not provide details about the specific acceptance criteria for these tests, the performance metrics achieved, or the study design/results for demonstrating this substantial equivalence beyond this general statement.

In summary, the provided content is a regulatory submission for substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria and study results.

Summary

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510(k) Summary

Segmental Defect Replacement System

510(k) Summary prepared February 12, 1998

MANUFACTURER IDENTIFICATION

Metagen, LLC 428 Technology Drive East Menomonie, Wisconsin 54751

Official Contact Person Wesley D. Johnson President Telephone (715) 232-4880 Fax (715) 235-9570

Consultant/Representative Floyd G. Larson Pacific Materials and Interfaces 4329 Graydon Road San Diego, CA 92130 Telephone (619) 792-1235 Fax (619) 792-1235

DEVICE IDENTIFICATION

Proprietary Name Segmental Defect Replacement System

Common Name Segmental Defect Prosthesis

Classification Name and Reference Rod, Fixation, Intramedullary and Accessories, 21CFR 888.3020

Regulatory Classification

The Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of FDA has recommended Class II, Performance Standards, for this device.

Device Product Codes

Product Code 87HSB has been assigned to this device.

DEVICE DESCRIPTION

Intended Use

Design

Mechanical Characterization

The Segmental Defect Replacement System has been evaluated by use of the static and fairgue tests. It has been shown to be substantially equivalent to the predicate devices.

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SUMMARY: TABLE OF SUBSTANTIAL EQUIVALENCE

The Segmental Defect Replacement System is substantially equivalent to the following predicate devices:

Subject Device	Predicate Devices		Related Devices
Segmental DefectReplacement System	EZ-Fix MidshaftHumeralIntramedullary RodSystem.BiodynamicsTechnologies, Inc.(K962553)	Howmedica ModularProximal HumerusReplacement System.Howmedica(K954559)	Modular OncologySystem Technology.IntermedicsOrthopedics, Inc.(Sulzer Orthopedics)(K960626)	SOS Proximal Femur.Wright MedicalTechnology(K933281)	Modular Intercalary HumeralSpacer.Mayo Clinic
Intended Use
Reconstruction of thehumeral diaphysis withan extensive destructivebone lesion due tometastatic disease,myeloma, or lymphoma,that places the humerusat risk for pathologicfracture	Midshaft fractures ofthe humerus	Replacements of theproximal humerussecondary toextensive bone loss orbone disease. Boneloss can be due totumor resection,revision arthroplastyor trauma.	Replacement of theproximal, distal or totalfemur where the amountof femoral resection andrestoration is extreme(e.g., in oncologycases).	Procedures in which avariable resection lengthprosthesis is necessary toaccommodate thecondition of the femur,e.g., severe bone loss inhip arthroplasty forosteosarcoma or fracturedfemur or revisionarthroplasty.	Pathological fracture,impending pathologicalfracture or failure ofattempted internal fixationtechniques secondary tosegmental destructive bonelesions of the humeraldiaphysis in disseminatedmalignancies
Design
Modular bistemmedintramedullary rodsystem with rigid camlocking mechanismdesigned to provideintraoperative adjustmentafter cementingcomponents into theproximal and distalsegments of the resectedhumerus.	Intramedullary rodsystem with screwholes, to be usedwithout bone cement	Modular humeralreplacement system,consisting of head,body and stemsegments. Cemented.	Modular hip and kneesystem consisting of aproximal femoralreplacement,intramedullary stemsand femoral segments, adistal femoralreplacement whichmates with a tibialcomponent, and apatella.	Modular hip systemconsisting of a femoralneck component, anoptional mid-sectioncomponent and a stemcomponent with Morsetaper connections.Cemented.	Modular bistemmedintramedullary rod systemwith conical couplingmechanism locked with setscrews designed to provideintraoperative adjustmentafter cementing componentsinto the proximal and distalsegments of the resectedhumerus.
Materials
Ti-6Al-4VNiTi alloy (lockingsystem)	Ti-6Al-4V	Co-Cr-Mo alloy (headand stem)Ti alloy (body)	Ti-6Al-4VUHMWPE (patella)	Ti-6Al-4V	Ti-6Al-4V

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 1998

Mr. Wesley D. Johnson President Metagen, LLC 428 Technology Drive East Menomonie, Wisconsin 54751

Re : K980609 Trade Name: Segmental Defect Replacement System Regulatory Class: II Product Code: нав Dated: February 17, 1998 Received: February 17, 1998

Dear Mr. Johnson:

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 of the Act. The general controls provisions 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. पुर 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 regulations.

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Page 2 - Mr. Wesley D. Johnson

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 regulation (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., M

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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Device Name: SEGMENTAL DEFECT REPLACEMENT SYSTEM、长980609

The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive desion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.

The Clinical Indication for Use is:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use _X

Over-the-Counter Use

signature

on Sion-Off Division of General Restorative I 510(k) Number

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.