(160 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the femoral heads, with no mention of AI or ML.
Yes
The device is a component of a hip replacement system, indicated for treating conditions like arthritis, hip dysplasia, and avascular necrosis, which directly alleviate pain and restore function in affected patients.
No
The device is a femoral head intended for mechanical fixation in total or partial hip arthroplasty, which is a therapeutic treatment. It does not perform any diagnostic function.
No
The device description clearly details physical components made of titanium alloy and ceramic, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "mechanical fixation to a mating hip stem" and is indicated for the "treatment of patients who are candidates for total or partial hip arthroplasty". This describes a surgical implant used in vivo (within the body) for structural support and joint replacement.
- Device Description: The description details the materials and components of a physical implant (femoral head and sleeve) designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The MectaCer BIOLOX® OPTION femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
- · Severely painful and/or disabled joint as a result of osteoarthritis, post-
- traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis,
- · Congenital hip dysplasia,
- · Ankylosing spondylitis,
- · Avascular necrosis of the femoral head,
- · Acute traumatic fracture of the femoral head or neck,
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.
Product codes
LZO
Device Description
The Mectacer Biolox Option Heads consist of a metal sleeve made of titanium alloy Ti-6AI4V according to ISO 5832-3 and ASTM F136 in neck lengths of S, M, L, and XL with an inner 12/14 taper and a MectaCer BIOLOX® OPTION ceramic femoral head (made of BIOLOX® delta ceramic) with head diameters of 28, 32, 36, 40, and 44mm with a conical bore which matches with the external taper of the sleeve. The MectaCer BIOLOX® OPTION femoral heads are made of high-purity aluminium oxide Al2 03-ZrO2 ceramic compound according to ISO 6474-2. The pink color is due to the chromium oxide (Cr2O3) that improves the hardness of the composite material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature
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)
The Mectacer Biolox Option Heads were tested for fretting corrosion of the metallic sleeve and the tapers of the femoral stems. These tests were conducted on Ti6Al7Nb (ISO 5832-11) femoral stems. In addition, the Mectacer Biolox Option Heads were tested for burst strength, fatique, post-fatique, pull-off and rotational stability. A review of the mechanical data indicates that the MectaCer Biolox Delta Heads are equivalent to devices currently cleared for use and are capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073337, K112115, K082996, K093549
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K131518 Page 1 of 3
Image /page/0/Picture/1 description: The image shows the word "Medacta" in a sans-serif font, with a geometric shape above the first letter. Below the word is a dashed line. Underneath the dashed line, the word "International" is written in a smaller font. To the right of the word "International" is a small square with a plus sign inside.
510(k) Summary
Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
NOV 0 4 2013
Contact Person: Adam Gross Director of Requlatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: May 27, 2013
DEVICE INFORMATION
Trade/Proprietary Name: Mectacer Biolox Option Heads Common Name: Ceramic Femoral Heads
- Classification Name: Hip Joint, metal/ceramic/polymer, semi-constrained, cemented or non-porous, uncemented prosthesis
21 CFR 888.3353 Class II Device Product Codes: LZO
Predicate Devices:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K073337 | MectaCer Biolox Forte Heads | Medacta International | 2/13/2008 |
| K112115 | MectaCer Biolox Delta Heads | Medacta International | 10/7/2011 |
| K082996, | Biolox Delta Option Ceramic Heads | Biomet | 1/15/2009, |
| K093549 | 12/16/2009 |
Mectacer Biolox Option Heads 510(k)
Section 5 - Page 2 of 4
1
Product Description
The Mectacer Biolox Option Heads consist of a metal sleeve made of titanium alloy Ti-6AI4V according to ISO 5832-3 and ASTM F136 in neck lengths of S, M, L, and XL with an inner 12/14 taper and a MectaCer BIOLOX® OPTION ceramic femoral head (made of BIOLOX® delta ceramic) with head diameters of 28, 32, 36, 40, and 44mm with a conical bore which matches with the external taper of the sleeve. The MectaCer BIOLOX® OPTION femoral heads are made of high-purity aluminium oxide Al2 03-ZrO2 ceramic compound according to ISO 6474-2. The pink color is due to the chromium oxide (Cr2O3) that improves the hardness of the composite material.
Indications for Use
The MectaCer BIOLOX® OPTION femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
- · Severely painful and/or disabled joint as a result of osteoarthritis, post-
- traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis,
- · Congenital hip dysplasia,
- Ankylosing spondylitis,
- · Avascular necrosis of the femoral head,
- · Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery; ioint reconstruction, internal fixation. arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.
Comparison to Predicate Devices
The indications for use, design features and materials of the Mectacer Biolox Option Heads are substantially equivalent to those of the predicate devices. The safety and effectiveness of the Mectacer Biolox Option Heads are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Performance Testing
The Mectacer Biolox Option Heads were tested for fretting corrosion of the metallic sleeve and the tapers of the femoral stems. These tests were conducted on Ti6Al7Nb (ISO 5832-11) femoral stems. In addition, the Mectacer Biolox Option Heads were tested for burst strength, fatique, post-fatique, pull-off and rotational stability.
2
A review of the mechanical data indicates that the MectaCer Biolox Delta Heads are equivalent to devices currently cleared for use and are capable of withstanding expected in vivo loading without failure.
Conclusion:
Based on the above information, the Mectacer Biolox Option Heads can be considered as substantially equivalent to its predicate devices.
Section 5 - Page 4 of 4
3
Image /page/3/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of an abstract human figure with outstretched arms, representing care and protection. The overall design is simple and recognizable, conveying the department's mission of promoting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2013
Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K131518
Trade/Device Name: Mectacer Biolox Option Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: October 4, 2013
Received: October 7, 2013
Dear Mr. Gross:
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
4
Page 2 - Mr. Adam Gross
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
.
Sincerely yours.
ErinFldKeith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131518
Device Name: Mectacer Biolox Option Heads
Indications for Use:
The MectaCer BIOLOX® OPTION femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
- · Severely painful and/or disabled joint as a result of osteoarthritis, post-
- traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis,
- · Congenital hip dysplasia,
- · Ankylosing spondylitis,
- · Avascular necrosis of the femoral head,
- · Acute traumatic fracture of the femoral head or neck,
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.
x ____________________________________________________________________________________________________________________________________________________________________________ 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)
Elizabeth L. Frank -S
Division of Orthopedic Devices