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 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 36mm femoral heads and 36mm inserts.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a line extension of the Cardo Medical Hip System, specifically the addition of 36mm femoral heads and inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone clinical study with human subjects.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in the context of this 510(k) submission. The document focuses on demonstrating that the new components do not introduce new questions of safety or effectiveness compared to the existing, cleared device and its predicates.

Here's an analysis based on the information provided, highlighting why certain sections are N/A:

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

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, the acceptance criteria for this 510(k) submission are implicitly met by demonstrating substantial equivalence to existing predicate devices. This means the new components must demonstrate similar technological characteristics and the same intended use as the predicates, and not raise new questions of safety or effectiveness.
Reported Device Performance: The "performance" here refers to the new components being "equivalent" to the predicate devices in materials, design, packaging, and sterilization. No new performance data (e.g., in terms of clinical outcomes or diagnostic accuracy) compared to defined criteria is presented.

Feature/Characteristic	Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance
Intended Use	Same as predicate devices	"The Cardo Medical Hip System components are for use in total hip arthroplasty as a result of: Hip arthritis..., Correction of functional deformity..., Avascular Necrosis..., Treatment of non-unions..., Difficult clinical management problems..." (Same as predicate)
Technology	Similar to predicate devices (materials, design, sterilization)	"The proposed 36mm cobalt chrome femoral heads have the same 12/14 trunnion taper as the previously... cleared... The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in materials, design, packaging, and sterilization..."
Performance	Not raise new questions of safety or effectiveness	"Testing has shown that the proposed device eliminates requirements on total hip arthroplasty product and the proposed device is equivalent to the predicate device." "This 510(k) is for the addition of 36mm femoral heads and inserts. These heads and inserts do not present a worst-case scenario (the 28mm femoral head component with the +12mm offset); therefore the previous testing applies to these components."
Sterility	Sterile, single use, SAL of 10⁻⁶	"All Cardo medical implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10⁻⁶."
Material	Equivalent to predicate devices	"The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in materials..."
Design	Equivalent to predicate devices	"The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in... design..."
Packaging	Equivalent to predicate devices	"The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in... packaging..."
Sterilization	Equivalent to predicate devices (gamma sterilized for heads and inserts)	"The heads are gamma sterilized." "The inserts are gamma sterilized." (Same as predicate)

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

N/A. This submission is not based on a clinical test set or data from human subjects but on demonstrating equivalence through technical characteristics (materials, design, etc.) and referencing existing biocompatibility and mechanical testing data for the "worst-case" predicates. No specific patient data or provenance is mentioned.

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)

N/A. This submission does not involve a test set requiring expert ground truth establishment in a clinical context.

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

N/A. Not applicable, as there is no clinical test set requiring adjudication.

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

N/A. This device does not involve AI or human image interpretation; it is a physical medical implant. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

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

N/A. Not applicable, as this device is a physical implant, not an algorithm.

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

N/A. Ground truth of this nature is not applicable to a 510(k) submission for a line extension of an orthopedic implant. The "truth" in this context is the regulatory determination of substantial equivalence based on engineering and materials data, and comparison to already cleared devices.

8. The sample size for the training set

N/A. Not applicable. The device is a physical implant, not a software algorithm requiring a training set.

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

N/A. Not applicable, as there is no training set mentioned or implied for this device.

Summary

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Cardo Medical Hip Components Premarket Notification Submission - 510(k)

094045

Page 1 of 2

510(k)_Summary of Safety and Effectiveness

Submitter:	Michael KvitnitskyCardo Medical, Inc.10 Clifton Blvd., Suite B1Clifton, NJ 07011Tel: 973-777-8832, ext. 302Fax: 973-777-8851	APR 22 2010
Date Prepared:	April 12, 2010
Device:	Cardo Medical Hip System
Classification:	87 LPH and 87 HWC - Hip joint metal/polymer/metal semi-constraineduncemented prosthesis, 21 CFR 888.3358 Class II
Predicate Devices:	Accin™ Hip System (now Cardo Medical Hip System) - K073068Exactech 12/14 Total Hip System (Exactech, Inc.) - K041906, K993082
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 36mm femoral heads and 36mm inserts.
Intended 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 resultsThese components are single use only and are intended for implantation without bone cement.

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Comparison to Predicates:

The proposed devices are a line extension to add 36mm femoral heads and inserts.

Femoral Stems

r enoral stems
There has been no change to the existing femoral stems, available in 21 sizes from 6mm to 22.5mm with a regular or lateral offset. The stems are gamma irradiated.

Femoral Heads

The proposed 36mm cobalt chrome femoral heads have the same 12/14 trunnion taper as the previously The proposal ounline oblines to the les 22, 26, 28 and 32 mm OD in a variety of offsets (K073068). The 36mm femoral head will have offsets of -5, -3.5, 0, +3.5 and +5mm. The prior offsets ranged from -3.5 to +12mm with the +12mm being the worst case. The heads are gamma sterilized.

The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in materials, design, packaging, and sterilization and equivalent to the Exactech 12/14 total hip system femoral heads in size.

Acetabular Shells

There has been no change to the existing acetabular shells. They are designed to mate with the acetabular inserts with a permanently inserted retaining ring and have three clustered holes for bone screws, if necessary. Each shell has a size that matches it to the correct inserts and are gamma sterilized.

Acetabular Inserts

Accrabular Moorts inserts (K073068). The prior inserts are offered in standard and 10° hooded variations. The proposed insorts (not over, "The prior inserts are available in 22mm, 26mm, 26mm, 26mm, and 32mm inner diameter sizes. They are designed to mate with the previously cleared acetabular shells. Each liner has a size designation that metches it to the correct mating shell component. The new 36mm acetabular liners are designed to articulate with the proposed 36mm Cardo Medical coball chrome femoral heads. The inserts are gamma sterilized.

The proposed 36mm inserts are equivalent to the Accin Hip System (K073068) in materials, design, r no proposod ountil into to and equivalent to the Exactech 12/14 total hip system inserts in ID and OD.

Bone Screws

There has been no change to the existing titanium alloy bone screws cleared in K073068, which are in a There has boon no enange to are extram 15mm to 60mm. The screws are gamma sterilized.

Summary

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 or encourtiness of the hip typestify to the numents on total hip arthroplasty product and the proposed device is equivalent to the predicate device.

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

Synopsis of Test Methods and Results:

This 510(k) is for the addition of 36mm femoral heads and inserts. These heads and inserts do not r his STO(K) is for the duallion of commiss ( the 28mm femoral head component with the +12mm offset); therefore the previous testing applies to these components.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

APR 2 2 2010

Cardo Medical, Inc. % Mr. Mike Kvitnitsky Chief Operating Officer and President 10 Clifton Boulevard, Suite Bl Clifton, New jersey 07011

Re: K094045

Trade/Device Name: Cardo Medical Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, HWC Dated: February 11, 2010 Received: February 16, 2010

Dear Mr. Kvitnitsky:

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

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Page 2- Mr. Mike Kvitnitsky

device-related adverse events) (21 CFR 803); 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.

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 vours.

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

94047 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 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)

Sputa for mkn

Page 1 of 1

(Diffision Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K094045

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.