Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-Hip Replacement: Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated: irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

Device Description

The hydroxyapatite tricalcium phosphate coated HGP Total Hip System is modular in design and consists of four basic components: The hip stem, the femoral head, the acetabular component and the liner. The Acetabular Components also have an HA/TCP coating. The HGP Total Hip is a femoral component made from Tivanium® Ti-6A1-4V Alloy. The femoral stem is straight and similar to that of other conventional total hip stems. In addition, commercially pure titanium fiber pads of approximately 2 mm thickness are metallurgically bonded to the anterior, posterior, lateral and medial aspects of the stem body. The proximal one-third of the stem is coated with HA/TCP which is applied by a plasma spraying process. This coating is approximately 20 to 50 microns in thickness. The plasma spray feedstock and resultant coating consists predominantly of calcium hydroxyapatite with minor components of betatricalcium phosphate and other calcium phosphates. The modular connection of the femoral stem is a Morse type 6° taper designed to mate with the corresponding 6° bore of a femoral head component. The femoral heads are available in 22, 26, 28, and 32 mm diameters. The modular nature of the system allows for the use of a variety of neck lengths, offsets, and femoral head diameters. The devices may also be used with endoprostheses. This ceramic is colorless. The measurement of a calcium phosphate ceramic's chemical composition involves determination of the calcium/phosphorus ratio and trace metals content by elemental analysis. The distribution among different crystalline phases is determined by powder X-ray diffraction, which has an accuracy of approximately 10 percent for any given phase in a multiphasic, moderately crystalline calcium phosphate ceramic. The device is designed to fit the upper end of the femur and provide an interference fit with intimate contact between the porous titànium pads and the surrounding bone. This fibrous titanium mesh HA/TCP sufface has a porous morphology which provides a scaffold-like structure into which biological tissues may ingrow, thus fixing or anchoring the prosthesis.

AI/ML Overview

This document is a 510(k) summary for the Harris/Galante Porous Hip Prosthesis With HA/TCP Coating. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., a formal clinical trial with quantitative performance metrics).

The FDA's review for a 510(k) submission determines substantial equivalence to a legally marketed predicate device, rather than establishing new acceptance criteria or conducting a study to prove performance against predetermined metrics. The summary focuses on comparing the new device to existing predicate devices based on design, materials, and intended use.

However, I can extract information related to the device description, intended use, and comparison to predicate devices, which implicitly address safety and effectiveness as judged by substantial equivalence.

Here's an analysis based on the provided text, addressing the points where possible:

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

This document does not present a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported device performance against such metrics. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is indirectly assured by the history of successful clinical use of the materials and design principles in predicate devices.

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

Not applicable. This is not a study assessing performance of the device against a test set in the traditional sense of a clinical trial for diagnostic devices or AI algorithms. The submission is for a medical implant and relies on "clinical and nonclinical data" that support the principle of biologic fixation through bone ingrowth (Page 2). Specific clinical study data with sample sizes, data provenance, or study design (retrospective/prospective) are not detailed in this summary.

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)

Not applicable. There is no mention of "ground truth" establishment by experts in the context of a test set for this 510(k) submission.

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

Not applicable. No test set or adjudication method is described.

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

Not applicable. This device is a hip prosthesis, not a diagnostic imaging aid or an AI-powered system designed to assist human readers.

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

Not applicable. This is a physical medical device (hip prosthesis), not an algorithm.

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

Not applicable. The concept of "ground truth" as applied to diagnostic algorithms is not relevant here. The "truth" for this device's safety and effectiveness is established by its substantial equivalence to existing, legally marketed predicate devices that have a history of successful clinical use. The "clinical and nonclinical data" mentioned are used to support this equivalence, particularly regarding biologic fixation. The FDA specifically states: "The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation, only)." (Page 3-4)

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or machine learning as this is a physical medical device.

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

Not applicable.

Summary of Device and Evidence Presented in the 510(k):

Device Name: Harris/Galante Porous Hip Prosthesis With HA/TCP Coating

Intended Use/Indications:

Total Hip Replacement: Severe hip pain and disability due to various conditions including rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, nonunion of fractures, congenital hip dysplasia, etc. Also for previously failed endoprostheses and acute femoral neck fractures.
Hemi-Hip Replacement: Fracture dislocation of the hip, irreducible fractures, certain high subcapital and comminuted femoral neck fractures in the aged, nonunion of femoral neck fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis primarily affecting the femoral head, especially in elderly, debilitated patients where total hip replacement is contraindicated.

Basis for Acceptance (Substantial Equivalence):

The submission demonstrates substantial equivalence to previously cleared predicate devices, including:

Harris/Galante Porous Hip Prosthesis (K-840643, cleared April 17, 1984)
TCP-Coated Porocoat AML Femoral Hip Prosthesis (K-964650, cleared June 6, 1997)
HGP II Acetabular Stem (K-921308, cleared February 22, 1994)
Inter-Op HA Porous Acetabular System (K-972393, cleared September 19, 1997)

Key arguments for substantial equivalence:

Intended Use: All predicate devices and the HGP Hip Prosthesis are intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum.
Design/Technology: All feature a porous or roughened surface and are modular in design. Each has a Morse-type proximal neck taper that mates with a femoral head, which articulates with a UHMWPE bearing surface.
Materials: All predicate devices and the HGP Hip Prosthesis are manufactured from metal alloys (Tivanium® Ti-6A1-4V Alloy) that have a history of successful clinical use in orthopedic applications. The HGP features a HA/TCP coating applied by plasma spraying, with specific composition and thickness described.
Performance Claim: The device is designed to achieve biologic fixation to bone through bone ingrowth. The FDA limited the claims to "biological fixation, only," emphasizing that the data supported equivalence without additional claims of "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation."

In essence, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which provides a comparative analysis to predicate devices and asserts that the new device is as safe and effective as those already on the market. The FDA's clearance (NOV 1 2 1998) confirms this finding of substantial equivalence.

Summary

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K 980711

Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. The logo is black and white.

NOV 1 2 1998

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

Summary of Safety and Effectiveness

Submitted By: .

Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131

Contact Person: .

Ruth Wood Senior Regulatory Affairs Associate Telephone: 219/372-4944 Telefax: 219/372-4605

Date: ●

February 23, 1998

Trade Name: .

Harris/Galante Porous Hip Prosthesis With HA/TCP Coating

Common Name: .

Femoral Hip Prosthesis

Classification Name: .

Hip Joint Metal/Polymer/Metal Semiconstrained Porous-Coated Uncemented Prosthesis

Stems:

Harris/Galante Porous Hip Prosthesis, K-840643, cleared April 17, 1984 ♪
Image /page/0/Picture/20 description: The image shows a hexagon that is divided into six equilateral triangles. Each of the six triangles is further divided into three smaller triangles. The smaller triangles are arranged in a way that creates a three-dimensional effect, making it appear as if the triangles are folded or layered on top of each other. The overall design is symmetrical and geometric.

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TCP-Coated Porocoat AML Femoral Hip Prosthesis, K-964650, cleared ♪ June 6, 1997

Acetabular Cups:

HGP II Acetabular Stem, K-921308, cleared February 22, 1994 ♪
Inter-Op HA Porous Acetabular System, K-972393, cleared ♪ September 19, 1997

Device Description

The HGP Total Hip is a femoral component made from Tivanium® Ti-6A1-4V Alloy. The femoral stem is straight and similar to that of other conventional total hip stems. In addition, commercially pure titanium fiber pads of approximately 2 mm thickness are metallurgically bonded to the anterior, posterior, lateral and medial aspects of the stem body.

The proximal one-third of the stem is coated with HA/TCP which is applied by a plasma spraying process. This coating is approximately 20 to 50 microns in thickness. The plasma spray feedstock and resultant coating consists predominantly of calcium hydroxyapatite with minor components of betatricalcium phosphate and other calcium phosphates.

The modular connection of the femoral stem is a Morse type 6° taper designed to mate with the corresponding 6° bore of a femoral head component. The femoral heads are available in 22, 26, 28, and 32 mm diameters. The modular nature of the system allows for the use of a variety of neck lengths, offsets, and femoral head diameters. The devices may also be used with endoprostheses.

This ceramic is colorless. The measurement of a calcium phosphate ceramic's chemical composition involves determination of the calcium/phosphorus ratio and trace metals content by elemental analysis. The distribution among different crystalline phases is determined by powder X-ray diffraction, which has an accuracy of approximately 10 percent for any given phase in a multiphasic, moderately crystalline calcium phosphate ceramic.

The device is designed to fit the upper end of the femur and provide an

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interference fit with intimate contact between the porous titànium pads and the surrounding bone. This fibrous titanium mesh HA/TCP sufface has a porous morphology which provides a scaffold-like structure into which biological tissues may ingrow, thus fixing or anchoring the prosthesis.

Intended Use/Indications

Total Hip Replacement:

Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis: disability due to previous fusion: previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-Hip Replacement:

Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

Comparison to Predicate Devices

All hip systems listed above are substantially equivalent to each other and the HGP Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the . femur and/or acetabulum. All predicate devices feature a porous or roughened surface and are modular in design. Each has a Morse-type proximal neck taper that mates with a femoral head which, in turn, articulates upon the ultra-high molecular-weight polyethylene (UHMWPE) bearing surface of a total hip or hemi-hip acetabular component. All predicate devices and the HGP Hip Prosthesis are manufactured from metal alloys that have a history of successful clinical use in orthopaedic applications.

Clinical and Nonclinical Data .

The HGP Hip Prosthesis is an example of a device designed to achieve biologic fixation to bone through bone ingrowth.

RA12702K.510

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's authority and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1998

لال ا

Toni R. Kingsley, Ph.D. Director, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K980711 Harris/Galante Hip System with Calicoat® Ceramic Coating Requlatory Class: II Product Codes: LPH and MEH Dated: Auqust 19, 1998 Received: Auqust 21, 1998

Dear Dr. Kingsley:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Toni R. Kingsley, Ph.D.

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f.) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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. 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 obliqation 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 yitro diaqnostic 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Toni R. Kingsley, Ph.D.

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,

C. Cole M. Witten, Ph.D., M.

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

Enclosure

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Exhibit V

Indications for Use

Page _ 1_ of __ 1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Harris/Galante Porous Hip Prosthesis with HA/TCP Coating

Indications for Use:

The Harris/Galante Hip Prosthesis is designed for implantation into the human joint in total hip or hemi-hip replacement and is indicated for the following:

Total Hip Replacement:

Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-Hip Replacement:

Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated: irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

(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)

RA12702K.510

Over-The-Counter Use __
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980711

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.