(134 days)
Not Found
No
The 510(k) summary describes a line extension for a hip replacement system, specifically adding ceramic femoral heads. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical testing of the physical components.
Yes
The device is a component of a total hip arthroplasty system, which is used to treat various medical conditions affecting the hip, such as arthritis, avascular necrosis, and fractures, with the aim of restoring function and alleviating pain. This directly aligns with the definition of a therapeutic device.
No
The provided text indicates that the device components are for use in total hip arthroplasty to correct hip arthritis and other related conditions. This describes a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy, cobalt chrome, UHMWPE, and alumina ceramic, which are hardware implants for total hip arthroplasty.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used in total hip arthroplasty. It is a physical component (ceramic femoral head) intended to be surgically placed within the body to replace a damaged hip joint.
- Lack of Diagnostic Function: The device does not perform any diagnostic testing on biological samples. Its purpose is to restore function and alleviate pain in a damaged hip joint.
Therefore, based on the provided information, the Cardo Medical Ceramic Head components are a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance: All mechanical testing required by the guidance 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 07011
Tel: 973-777-8832, ext. 330
Fax: 973-777-8851
Email: 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 or
non-porous, uncemented, 21 CFR 888.3353 Class II |
| Predicate Device: | Accin™ Hip System (now Cardo Medical Hip System) - K073068, K094045
Stelkast 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 to
add 32mm and 36mm alumina ceramic femoral heads. |
| Intended Use: | 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. |
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.
Page 1 of 2
1
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.
Page 2 of 2
2
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
3
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
4
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)
OR
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)
Page 1 of 1
Suita for mxn
(Devision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100008