The MARGRON™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Osteoarthritis, Rheumatoid arthritis, Tumor conditions involving the upper third of the femur or the acetablym, Ankylosing spondylitis, Psoriatic arthritis, Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein, Non union of femoral neck fracture or avascular necrosis of the femoral head, Post-traumatic fracture/dislocation of the hip, Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling, Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present, Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Device Description

The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The MARGRON TM Femoral Stem is a modular prosthesis consisting of - A tapering stem cone with two different speed external threads and longitudinal . derotation columns. - A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion. - . Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation. - . A unique set of instruments have been designed to insert and extract the prosthesis.

AI/ML Overview

The provided document is limited to a Special 510(k) Notification for the MARGRON™ Hip Replacement System, asserting substantial equivalence to an existing predicate device (K992158). This type of submission generally relies on demonstrating that changes to a previously cleared device do not introduce new questions of safety or effectiveness.

Therefore, the document does not contain the detailed information typically found in a study demonstrating performance against specific acceptance criteria for a novel device. It refers to the testing of the original design of the predicate device.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states: "All materials used in the fabrication of this MARGRON™ Hip Replacement System were evaluated with the original design through physical testing (fatigue, torque and corrosion testing) and biocompatibility testing. It has been shown to be substantially equivalent to the predicate device."

This implies that the original device underwent testing, and the current device's materials are equivalent to those used in the original. However, specific acceptance criteria for these tests and the detailed results are not presented.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document makes generic statements about "physical testing" and "biocompatibility testing" of the "original design," but no details about sample sizes or data provenance are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/provided. Since this is a physical medical device (hip replacement system) and not a diagnostic AI/software, the concept of "ground truth" established by human experts in the context of a test set (e.g., for image interpretation) does not apply. The testing mentioned (fatigue, torque, corrosion, biocompatibility) are laboratory-based physical and chemical tests, not clinical evaluations requiring expert interpretation of results in the same way.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. This is a physical hip replacement implant, not an AI or diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. This is a physical hip replacement implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided. As explained in point 3, the testing involves physical and chemical property assessments, not diagnostic evaluations requiring a "ground truth" derived from expert consensus, pathology, or outcomes data. The "ground truth" for material properties would be established by validated scientific methodologies and standards.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" applies to machine learning and AI, which is not relevant to this physical implant device.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as point 8.

In summary:

The provided document is a regulatory submission for a hip replacement system, focusing on demonstrating substantial equivalence to a predicate device based on similar design and materials. It does not provide details about specific acceptance criteria or performance studies in the format requested, as these are typically part of a full Premarket Approval (PMA) application or a more extensive 510(k) for a novel device, especially for AI/software products. The testing mentioned pertains to the physical and biocompatible properties of the materials used in the original design of the predicate device.

Summary

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032641

Summary of Safety and Effectiveness 10.

Manufacturer:	Portland Orthopaedics Pty. Ltd.Unit 3, 44 McCauley StreetMatraville, NSW, 2036Australia
Contact:	David SekelCEO, Portland Orthopaedics
Telephone Number:	011 (61) 2 9666 8444
Fax Number:	011 (61) 2 9666 8544
Date Summary Prepared:	August 15, 2003
Product Trade Name:	MARGRON™ Hip Replacement System
Common Name:	Modular Femoral Hip Replacement System
Classification Name:	Hip joint/ceramic/polymer semi-constrainedCemented or nonporous uncemented prosthesis
Product Codes:	87 MEH & LPH - Device, Fixation, ProximalFemoral, Implant
Predicate Device:	MARGRON™ Hip Replacement System(K992158)

Page 1 of 3

MARGRON™ Hip Replacement System Special 510(k) Notification

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KO32641

Device Description:

The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly.

The MARGRON TM Femoral Stem is a modular prosthesis consisting of

A tapering stem cone with two different speed external threads and longitudinal . derotation columns.
A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion.
. Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation.
. A unique set of instruments have been designed to insert and extract the prosthesis.

Intended Use/Indications:

The MARGRONTM Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present.

The patient should be skeletally mature. The patient's condition should be due to one or more of the following:

Osteoarthritis ●
. Rheumatoid arthritis
. Tumor conditions involving the upper third of the femur or the acetablym
Ankylosing spondylitis .
Psoriatic arthritis .
� Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein
. Non union of femoral neck fracture or avascular necrosis of the femoral head
. Post-traumatic fracture/dislocation of the hip
. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
Revision of an unsuccessful cemented or un-cemented hip replacement stem, . providing sufficient bone stock is present
Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup . arthroplasty or hemi arthroplasty.

Page 2 of 3

Portland Orthopaedics Pty. Ltd. MARGRONTM Hip Replacement System Special 510(k) Notification

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(03244)

Substantial Equivalence:

The MARGRONTM Hip Replacement System is substantially equivalent to the current MARGRONTM Hip Replacement System (K992815) in that:

the intended use is the same ●
the same operating principles is used .
the same final design configuration is incorporated �
both are labeled as sterile, single patient use .
both are packaged and labeled using the same materials and processes �

Summary of Testing:

All materials used in the fabrication of this MARGRON™ Hip Replacement System were evaluated with the original design through physical testing (fatigue, torque and corrosion testing) and biocompatibility testing. It has been shown to be substantially equivalent to the predicate device.

Page 3 of 3

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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black.

Public Health Service

JAN 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Sekel CEO Portland Orthopaedics Pty. Ltd Unit 3, 44 McCauley Strect Matraville, NSW, 2036 Australia

Re: K032641 : Ito22011 Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH, LPH Dated: December 18, 2003 Received: December 22, 2003

Dear Mr. Sekel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Sekel

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 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), plcasc contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark N Milliman

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

Enclosure

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510(k) Number (if known): _

Device Name:

MARGRONTM Hip Replacement System

Indications for Use:

KO32641

The patient should be skeletally mature. The patient's condition should be due to one or more of the following:

Osteoarthritis .
Rheumatoid arthritis .
Tumor conditions involving the upper third of the femur or the acetablum .
Ankylosing spondylitis ●
Psoriatic arthritis .
Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein .
Non union of femoral neck fracture or avascular necrosis of the femoral head .
Post-traumatic fracture/dislocation of the hip �
Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where . low back pain or knee pain is becoming disabling
Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient . bone stock is present
Revision of a previous unsuccessful femoral ostcotomy, Girdlestone resection, cup arthroplasty or ◆ hemi arthroplasty.

(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)	X OR Over-The-Counter Use
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for

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

Mark N Millenson

Restorative

Medical Devices

K032641

Portland Orthopaedics Pty. Ltd. MARGRONTRA Hip Replacement System Special 510(k) Notification

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.