(116 days)
Not Found
No
The document describes a mechanical orthopedic implant and contains no mention of AI or ML technology.
No
The device is a unipolar prosthesis intended for use in hemiarthroplasty of the hip, replacing the femoral head and articulating directly with the patient's acetabulum. Its function is to replace a damaged or diseased anatomical part, which is consistent with a medical device rather than a therapeutic device that treats a condition.
No
The device is a prosthesis intended for surgical implantation to replace or repair part of the hip joint. It is not used to diagnose a medical condition.
No
The device description clearly states it is a "unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12)", which is a physical hardware component.
Based on the provided information, the Medacta® Endo Head is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a prosthesis for surgical implantation in the hip for conditions like fractures and osteonecrosis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of CoCrMo designed to articulate within the body. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Medacta® Endo Head does not fit this description.
N/A
Intended Use / Indications for Use
The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
· Femoral neck and trochanteric fractures of the proximal femur;
· Osteonecrosis of the femoral head;
· Revision procedures where other devices or treatments for these indications have failed.
Product codes
LZY
Device Description
The Medacta Endo Head is a unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12) designed to articulate directly in the patient's acetabulum. It is designed to be assembled with all the Medacta stems. Three sizes (S, M and L) are available for a 12/14 Morse taper with an outer diameter varying from 40 to 56 mm with 1 mm increments between sizes.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K896580, K062408, K072857, K080885, K103721
Reference Device(s)
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
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the handwritten text "K111145" above the logo for Medacta International. The Medacta logo features a stylized mountain range with the company name to the right. Below the logo, the word "International" is printed in a smaller font, and a plus sign is located to the right of the word.
AUG 1 6 2011
510(k) Summary
Manufacturer: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66
Contact Person: Adam Gross Director of Regulatory and Quality Medacta USA Office: 805-437-7085 x26 Cell: 805-910-6511 Fax: 805-437-7553 AGross@medacta.us.com
April 19th, 2011 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: Endo Head Common Name: Unipolar Head Classification Name: prosthesis, hip, hemi-, femoral, metal ball
21 CFR 888.3360 Class II Device Product Codes: LZY
Predicate Devices:
K896580 - Smith & Nephew Unipolar System K062408 - Smith & Nephew Modular Femoral (Hemi) Heads K072857 - Medacta CoCrMo Femoral Ball Heads, 28 and 32mm
- K080885 Medacta CoCrMo Femoral Ball Heads, 22 and 36mm K103721 - Medacta CoCrMo Femoral Ball Heads, 40mm
Endo Head 510(k)
Section 5 - Page Z of A
1
K川 45
Product Description
The Medacta Endo Head is a unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12) designed to articulate directly in the patient's acetabulum. It is designed to be assembled with all the Medacta stems. Three sizes (S, M and L) are available for a 12/14 Morse taper with an outer diameter varying from 40 to 56 mm with 1 mm increments between sizes.
Indications for Use
The Medacta Endo Head is intended for use in combination with Medacta Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
· Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.
Comparison to Predicate Devices
The Endo Head has the same intended use, material, neck lengths, and external diameter size range as the previously cleared Unipolar System manufactured by Smith and Nephew (K896580). The Endo Head's material, sterilization, biocompatibility, and coupling with the Medacta stems is substantially equivalent to the Medacta CoCr Femoral Heads cleared under K072857, K080885, and K103721.
Conclusion:
Based on the above information, the Endo Head can be considered as substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health. The logo features a stylized human figure with three lines representing the head, torso, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & H.", which is arranged in a circular fashion.
Food and Drig Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medacta International % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4275 Calle Quetzal. Unit B Camarillo, California 91302
AUG 1 6 2011
Re: K111145
Trade/Device Name: Endo Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LZY Dated: July 28, 2011 Received: July 29, 2011
Dear Mr. Gross:
We have reviewed vour 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
3
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/ReportalProblem/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,
Mark N. Mollenhour
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 Statement
510(k) Number (if known): K111145
Device Name: Endo Head
Indications For Use:
The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
· Femoral neck and trochanteric fractures of the proximal femur;
· Osteonecrosis of the femoral head;
· Revision procedures where other devices or treatments for these indications have failed.
Prescription Use × (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
for m. Mellers on
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111145
Section 4 - Page 2 of 2
Endo Head 510(k) July 28, 2011