The Cardo Medical Ceramic Head components are for use in total hip arthroplasty as a result of:
• Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip,
• Correction of functional deformity,
• Avascular Necrosis,
• Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur,
• Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results.

These components are single use only and are intended for implantation with or without bone cement.

Device Description

The previously cleared Cardo Medical Hip System consists of
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) femoral stems,
• cobalt chrome (CoCr) femoral heads,
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) acetabular shells,
• ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts, and
• titanium alloy (Ti-6Al-4V) bone screws.

The proposed devices are a line extension to the previously cleared system to add 32mm and 36mm alumina ceramic femoral heads.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cardo Medical Ceramic Head:

The document describes a Premarket Notification Submission (510(k)) for the Cardo Medical Ceramic Head, a line extension to an existing total hip arthroplasty system. This submission aims to demonstrate substantial equivalence to previously cleared devices rather than prove novel safety and effectiveness. Therefore, the "acceptance criteria" and "study" described are focused on meeting the requirements for demonstrating substantial equivalence through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined by FDA Guidance Document)	Reported Device Performance
Mechanical Testing Requirements for Ceramic Heads
Stem fatigue mechanical testing	Included in submission. Results indicate compatibility with previously cleared femoral heads and capability of withstanding in vivo loading.
Push-in, push-out, lever-out, and rotational torque forces for acetabular inserts	Included in submission. Results indicate compatibility with previously cleared femoral heads and capability of with vivo loading.
Range-of-Motion (oscillation) of the proposed system	Included in submission. Results indicate compatibility with previously cleared femoral heads and capability of withstanding in vivo loading.
Static burst testing of femoral heads	Included in submission. Results indicate the Cardo Medical ceramic femoral heads are equivalent to legally marketed devices.
Dynamic fatigue testing of femoral heads	Included in submission. Results indicate the Cardo Medical ceramic femoral heads are equivalent to legally marketed devices.
Axial Pull-Off testing of femoral heads	Included in submission. Results indicate the Cardo Medical ceramic femoral heads are equivalent to legally marketed devices.
Material Equivalence	Made from alumina ceramic, which is equivalent to the Stelkast ceramic femoral heads (predicate device K033944).
Design and Size Equivalence	Same 12/14 trunnion taper as previously cleared cobalt chrome femoral heads. Equivalent in size, design, and sterilization to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of how many individual devices were tested for each mechanical test. It refers to "technical reports for stem fatigue mechanical testing," "the push-in, push-out, lever-out and rotational torque forces for acetabular inserts," etc., implying standard engineering-level test matrices would have been used.

Data Provenance: The nature of the tests (mechanical performance, material equivalence) suggests these were laboratory-based tests conducted by the manufacturer or a contract testing facility. The data is non-clinical and focused on the physical and mechanical properties of the device components. There is no information regarding country of origin of the data beyond it being part of a US FDA submission. It is prospective in the sense that the testing was performed to support this specific submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable for a non-clinical, mechanical testing study for substantial equivalence. "Ground truth" in this context is defined by established engineering standards and test methodologies, and the acceptance criteria are based on those standards and comparison to predicate devices, not on expert clinical consensus. The experts involved would be engineers and material scientists performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical tests have objective, measurable outcomes that either meet or do not meet specified criteria. There is no subjective interpretation requiring adjudication among human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states under "Clinical Performance": "Clinical data and conclusions are not needed for this device." This is because the submission is for a material and dimensional modification (adding ceramic heads) to an already cleared system, relying on substantial equivalence to predicate devices and robust non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This is a medical device (a ceramic hip component), not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is based on:

Established engineering standards and test methods: The document mentions "required by the guidance document for ceramic heads."
Comparison to legally marketed predicate devices: The "results indicate that the Cardo Medical ceramic femoral heads and inserts is equivalent to devices currently legally marketed." This implies that the performance of the predicate devices in these mechanical tests (or accepted ranges for such devices) served as the benchmark.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the text "Cardo Medical Ceramic Head Premarket Notification Submission - 510(k)" on the left side of the image. On the right side of the image is the number K100008 written in cursive. The text on the left side of the image describes the document as a premarket notification submission for a Cardo Medical Ceramic Head. The number on the right side of the image is likely a reference or identification number for the submission.

MAY 1 8 2010

Summary of Safety and Effectiveness

Submitter:	Dina Weissman, J.D.Cardo Medical, Inc., 10 Clifton Blvd., Suite B1, Clifton, NJ 07011Tel: 973-777-8832, ext. 330Fax: 973-777-8851Email: dweissman@cardomedical.com
Date Prepared:	May 13, 2010
Device:	Cardo Medical Ceramic Hip System
Classification:	87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented ornon-porous, uncemented, 21 CFR 888.3353 Class II
Predicate Device:	Accin™ Hip System (now Cardo Medical Hip System) - K073068, K094045Stelkast 32mm Modular Ceramic Head - K033944
Device Description:	The previously cleared Cardo Medical Hip System consists of• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V)femoral stems,• cobalt chrome (CoCr) femoral heads,• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V)acetabular shells,• ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts, and• titanium alloy (Ti-6Al-4V) bone screws.The proposed devices are a line extension to the previously cleared system toadd 32mm and 36mm alumina ceramic femoral heads.
Intended Use:	The Cardo Medical Ceramic Head components are for use in total hiparthroplasty as a result of:• Hip arthritis caused by rheumatoid disease, non-inflammatory degenerativejoint disease, osteoarthritis, and arthritis resulting from biologic or mechanicaltrauma to the hip,• Correction of functional deformity,• Avascular Necrosis,• Treatment of non-unions, femoral neck and trochanteric fractures of theproximal femur,• Difficult clinical management problems involving persistent pain and physicalimpairment where conventional arthodesis is not likely to achieve satisfactoryresults.These components are single use only and are intended for implantation with orwithout bone cement.

Comparison to Predicates:

The Cardo Medical Ceramic Heads are manufactured from alumina ceramic and are for use with the currently marketed femoral stem, acetabular inserts and bone screws. The proposed devices are similar in design and materials to the Cardo Medical Total Hip System (K073068 and K094045) and the Stelkast Ceramic Heads (K033944).

Femoral Stems

There has been no change to the existing femoral stems.

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Cardo Medical Ceramic Head Premarket Notification Submission - 510(k)

Image /page/1/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K100008". The characters are written in black ink on a white background.

Femoral Heads

The proposed alumina ceramic femoral heads have the same 12/14 trunnion taper as the previously cleared cobalt chrome femoral heads, offered in sizes 22 through 36 mm OD in a variety of offsets (K073068 and K094045) and are equivalent in size, design, and sterilization. They are equivalent in material to the Stelkast ceramic femoral heads.

Acetabular Shells

There has been no change to the existing acetabular shells. They are designed to mate with the acetabular inserts and have holes for bone screws, if necessary.

Acetabular Inserts

There has been no change to the existing UHMWPE acetabular inserts, offered in sizes 22 through 36mm. They are designed to mate with the previously cleared acetabular shells.

Bone Screws

There has been no change to the existing titanium alloy bone screws cleared in K073068, which are in a 6.5mm diameter, in lengths from 15mm to 60mm.

All Cardo medical implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10-6.

Summary

Cardo Medical, Inc. has determined that any differences in the proposed device will not impact the safety or effectiveness of the hip system for its intended use. Testing has shown that the proposed device meets the requirements of the FDA Guidance document "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" and the guidance on total hip arthroplasty. The proposed device is substantially equivalent to the predicate device.

Synopsis of Test Methods and Results:

Nonclinical Performance

All mechanical testing required by the ĝuidance document for ceramic heads is included in this submission including technical reports for stem fatique mechanical testing; the push-in, push-out, leverout and rotational torque forces for acetabular inserts; the Range-of-Motion (oscillation) of the proposed system; and static burst testing, dynamic fatigue testing and Axial Pull-Off testing of the femoral heads. Results indicate that the Cardo Medical ceramic femoral heads and inserts is equivalent to devices currently legally marketed, is compatible with the previously cleared 12/14 femoral heads and capable of withstanding in vivo loading.

Clinical Performance

Clinical data and conculsions are not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardo Medical Inc. % Ms. Dina Weissman, J.D. Director, Quality Assurance, Regulatory Affairs and Government 10 Clifton Boulevard, Suite B1 Clifton, New Jersey 07011

MAY 18 2010

Re: K100008

Trade/Device Name: Cardo Medical Hip System 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: LZO Dated: April 30, 2010 Received: May 3, 2010

Dear Ms. Weissman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Dina Weissman, J.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Harbarbriclino

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

100008 510(k) Number (if known):

Device Name: Cardo Medical Hip System

Indications for Use:

The Cardo Medical Hip System components are for use in total hip arthroplasty as a result of:

. Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip
. Correction of functional deformity
Avascular Necrosis
. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur
. Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results

These components are single use only and are intended for implantation with or without bone cement.

Prescription Use × (Per 21 CFR 801.109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Suita for mxn

(Devision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100008

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.