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
Ankylosing spondylitis
Psoriatic arthritis
Old osteomyelitis with a long infection free period and a normal WBC, C- Reactive protein and ESR
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 uncemented or 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™ 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™ 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 a 510(k) summary for the Margron™ Hip Replacement System. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than novel devices requiring extensive clinical trials to demonstrate safety and effectiveness.

Therefore, the document does not contain information about a study designed to prove the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel medical device would. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed devices.

Because of this, I cannot extract the following information about acceptance criteria and a study proving their fulfillment:

A table of acceptance criteria and the reported device performance: This document doesn't define quantitative clinical "acceptance criteria" for the Margron system or report clinical performance against such criteria. The "Mechanical Characteristics" section mentions fatigue, torque, and corrosion tests were performed, and the results showed "substantial equivalence to the predicate devices," but no specific numerical criteria or performance data are provided.
Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" in the context of a comparative effectiveness study mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a hip replacement system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance study. The "ground truth" for substantial equivalence is defined by comparison to predicate devices, which involves design, materials, and intended use, not clinical outcomes from a specific study outlined here.
The sample size for the training set: Not applicable, as there's no 'training set' in the context of a clinical performance study for this type of device submission.
How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "acceptance criteria" and "proof":

The "acceptance criteria" for marketing approval of the Margron™ Hip Replacement System under a 510(k) pathway are based on demonstrating substantial equivalence to predicate devices already on the market.

Study/Evidence for Substantial Equivalence:

The document states:

"The Margron Hip is similar in design, materials and intended use to" a list of predicate devices (Metagen Modular Femoral Hip System, Biomet Impact, Mallory-Head, S-ROM, Infinity, Modular Hip System).
Mechanical Characteristics: "The Margron Hip System has been evaluated by use of the fatigue, torque and corrosion tests. It has been shown to be substantially equivalent to the predicate devices." (Page 3)
Materials: The material composition (Chrome Cobalt, Calcium Phosphate Coating) is specified and stated to be "implant grade materials." (Page 3)
Intended Use/Indications: The stated indications for use are similar to those typically found for hip replacement systems and are implied to be consistent with the predicate devices. (Page 2, Page 5)

In summary, for a 510(k) submission like this, the "study" is a comparison to predicate devices, and the "acceptance criteria" revolve around proving substantial equivalence in terms of design, materials, manufacturing processes, and performance (often assessed through non-clinical testing like mechanical tests). This is distinct from a clinical trial that evaluates specific performance metrics in human subjects against predefined clinical acceptance criteria.

Summary

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FEB r .. 2000

K 99+8/5

1083

ummary of Safety and Effectiveness

Submitter Name and Address:

Contact Person:

Date Summary Prepared:

Proprietary Name:

Common Name:

Classification Name:

Product Codes:

Portland Orthopaedics Pty. Ltd.
Suite 3 Level 5
St. George Private Hospital
1 South Street
Kogarah NSW 2217
Australia
Dr. Ronald Sekel
011 (61) 2 9588 2121

March 12, 1999

Margron™ Hip Replacement System

Modular Femoral Hip Replacement System

Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis.
21 CFR 888.3353
LPY/NEH
87 JDO - Device, Fixation, Proximal Femoral,
Implant

Predicate Devices:

The Margron Hip is similar in design, materials and intended use to:

Manufacturer	Metagen	Biomet	JointMedical/J&J	WrightMedicalTechnology	S&NRichards
System Name	ModularFemoralHipSystem(K980020)	Impact(K942027)	Mallory-Head(K921181)	S-ROM(K851422,K912713,K913231)	Infinity(K942115)	ModularHip System(RMHS)(K912593)

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K992815

2083

Device Description:

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

Osteoarthritis ●
. Rheumatoid arthritis
Ankylosing spondylitis
Psoriatic arthritis
Old osteomyelitis with a long infection free period and a normal WBC, C-. Reactive protein and ESR
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 uncemented or cemented hip replacement stem, providing sufficient bone stock is present
Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, . cup arthroplasty or hemi arthroplasty.

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KSS 2815

3083

Materials

Materials for components of the Margron™ Hip Replacement System are implant grade materials.

Material Composition of the Components:

Stem Chrome Cobalt (Cr Co) .

Calcium Phosphate Coating on upper half of stem .

Neck Chrome Cobalt (Cr Co) .

Chrome Cobalt (CrCo) per ASTM F-799-96

Mechanical Characteristics

The Margron Hip System has been evaluated by use of the fatigue, torque and corrosion tests. It has been shown to be substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Dr. Ronald Sekel Director Portland Orthopedics Pty. Ltd. Suite 3 Level 5 St. George Private Hospital 1 South Street Kogarah NSW 2217 Australia

Re: K992815

Trade Name: Margron Hip Replacement System Regulatory Class: II Product Code: MEH & LPH Dated: November 27, 1999 Received: November 30, 1999

Dear Dr. Sekel:

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. A 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 - Dr. Ronald Sekel

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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Nunell Sayer

Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K992815 510(k) Number (if known): New

Device Name:

Margron Hip Replacement System

Indication For Use:

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 ioint. 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 ●
Ankylosing spondylitis .
Psoriatic arthritis ●
Old osteomvelitis with a long infection free period and a normal WBC, C-. Reactive protein and ESR
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 uncemented or cemented hip replacement stem, ● providing sufficient bone stock is present
Revision of a previous unsuccessful femoral osteotomy, 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)

(Division Sion-Off)

Div Restorative Devices

510(k) Number `(9) 77877

Prescription Use
(Per 21 CFR 801.109)

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.