The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX® delta 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.

Device Description

The MectaCer Biolox Delta Heads are ceramic ball heads intended for mechanical fixation to a mating hip stem and indicated for the treatment of patients who are candidates for total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. The MectaCer Biolox Delta Heads are an aluminum oxide matrix composite ceramic consisting of approximately 75% alumina (Al₂O₃), 24% zirconia (ZrO₂) and other trace elements. The pink color is due to the chromium oxide (Cr2O3) that improves the hardness of the composite material. The MectaCer Biolox Delta Heads are designed to mate with a 12/14 stem taper. The MectaCer Biolox Delta Heads are available in head diameters of 28, 32, 36, 40, and 44 mm and in neck lengths of Small, Medium, Large, and Extra Large.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MectaCer Biolox Delta Heads, based on the provided text:

Important Note: This document describes a medical device clearance (510(k)) based on substantial equivalence, not a clinical trial proving a new therapeutic benefit. The "device performance" in this context refers to mechanical properties and comparison to predicate devices, not clinical outcomes.

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Burst Test	Defined by ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads. The modular connection between the ball and the stem of a hip prosthesis is loaded until failure.	Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading. (Specifically, the testing demonstrated that the MectaCer Biolox Forte Heads remain worst-case in comparison to the MectaCer Biolox Delta Heads, implying the Delta heads exceed the Forte's performance or at least meet its criteria).
Fatigue Test	Defined by CeramTec test procedure AA 02 10 0807. The modular connection between the ball and the stem of a hip prosthesis is loaded with a sinusoidal axial force at 10 million cycles.	Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading.
Post-Fatigue Test	Defined by ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads. The modular connection between the ball and the stem of a hip prosthesis is loaded until failure after the fatigue test.	Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading.
Rotational Stability Test ("Torsion Test")	Defined by Ceramtec procedure VP-KU-0180. A modular fitting between ball and stem is subjected to frictional torsion until movement occurs.	Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading.
Pull-Off Test	Defined by CeramTec procedure VP-KU-0210, with 5 samples (as per FDA recommendations). Corresponds to ISO 7206-10. The femoral head is pressed onto a taper using an axial force of 2 kN and pulled off axially using a loading rate of 1mm/min.	Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document explicitly mentions "5 samples" for the Pull-Off Test. For other tests (Burst, Fatigue, Post-Fatigue, Rotational Stability), the exact number of samples is not specified, but it states "The testing was conducted on the worst case size MectaCer Biolox Delta and Forte Heads."
- Data Provenance: The testing was conducted by or for Medacta International SA, a Swiss manufacturer. The tests themselves are based on international standards (ISO) and manufacturer-specific procedures (CeramTec). This is in vitro mechanical testing, not human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this study involves in vitro mechanical testing against established engineering standards and specifications, not human expert interpretation of clinical data. The "ground truth" is the performance defined by the ISO standards and CeramTec procedures.
Adjudication method for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical images or data. For mechanical testing, adherence to the pre-defined criteria of the test standards serves as the "adjudication."
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:
- No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a hip implant component, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is neither an algorithm nor a device with a human-in-the-loop component in the way usually meant in AI/diagnostic discussions. It is a standalone mechanical component for surgical implantation. The "standalone performance" here refers to its mechanical integrity under specified loads.
The type of ground truth used:
- The "ground truth" for this device's performance in mechanical testing is based on pre-defined acceptance criteria set by international standards (ISO 7206-10) and established internal manufacturer test procedures (CeramTec AA 02 10 0807, VP-KU-0180, VP-KU-0210). These standards prescribe the methodology and expected outcomes for material strength, fatigue resistance, and stability under load.
The sample size for the training set:
- This concept is not applicable here. There is no "training set" in the context of mechanical testing for a medical device implant. The device design and materials are based on established engineering principles and prior device history, not on machine learning training data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set." The "ground truth" for the device's design and manufacturing is established through extensive engineering research, material science, and adherence to medical device design requirements, industry standards, and regulatory guidance for orthopedic implants.

Summary

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K112115

OCT - 7 2011

Image /page/0/Picture/2 description: The image shows the word "Medacta" in a sans-serif font, with two triangles to the left of the word. Below the word "Medacta" is the word "International" in a smaller font. To the right of the word "International" is a small square with a plus sign in the middle.

510(k) Summary

Medacta International SA Manufacturer: 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 Requlatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com

Date Prepared: July 21, 2011

DEVICE INFORMATION

Trade/Proprietary Name: Mectacer Biolox Delta Heads Common Name: Femoral Heads Classification Name: Hip Joint, metal/ceramic/polymer, semiconstrained, cemented or non-porous uncemented prosthesis

21 CFR 888.3353 Class II Device Product Code: LZO

Predicate Devices: K073337 Medacta MectaCer BIOLOX® forte Femoral Heads K071535 Zimmer BIOLOX delta Ceramic Femoral Head K083762 Smith & Nephew Biolox Delta Ceramic Femoral Heads K100412 Smith & Nephew Biolox Delta Ceramic Femoral Heads - large sizes

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Product Description

Indications for Use

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.

Comparison to Predicate Devices

The MectaCer Biolox Delta Heads are substantially equivalent to K073337 Medacta MectaCer BIOLOX® forte Femoral Heads, K071535 Zimmer BIOLOX delta Ceramic Femoral Head, K083762 Smith & Nephew Biolox Delta Ceramic Femoral Heads, and K100412 Smith & Nephew Biolox Delta Ceramic Femoral Heads - large sizes. The MectaCer Biolox Delta Heads have the same indications for use as the MectaCer Forte Femoral Heads. The MectaCer Biolox Delta Heads have the same material as the Biolox Delta Heads cleared under K071535, K083762, and K100412. The MectaCer Biolox Delta Heads have the same head diameters as all of the predicate devices (28,32,36mm of the MectaCer Forte Heads; 28,32,36,40mm of the Zimmer Delta Heads; and 28,32,36,40,44mm of the Smith & Nephew Delta Heads). The MectaCer

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Biolox Delta Heads have the same neck lengths (S, M, L) as all of the predicate devices and also have the same XL neck length as the Zimmer Biolox Delta Heads.

Performance Testing

The MectaCer Biolox Delta and Forte Heads were tested as part of design verification to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on standards and FDA guidance. The testing was conducted on the worst case size MectaCer Biolox Delta and Forte Heads. The test on the Ti6Al7NB (ISO 5832-11) taper covers compatibility with Medacta's Quadra S (K072857), Quadra H (K082792), Quadra R (K082792), Quadra S-H/SN (K093944), and AMIStem H (K093944) femoral stems. The test on the High Nitrogen Stainless Steel (ISO 5832-9) taper covers compatibility with Medacta's Quadra C (K083558), Quadra C SN (K103189), and AMIStem C (K103189) femoral stems. The testing met all acceptance criteria and verifies that the performance of the MectaCer Biolox Delta Femoral Heads would be adequate for anticipated in vivo loading and that the MectaCer Biolox Forte Heads remain worst-case in comparison to the MectaCer Biolox Delta Heads.

The Burst Test was a compression test made under smooth load with a constant rate of 2mm/min according to ISO 7206-10 (ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads). The ball is placed on a conical bearing simulating the stem. The modular connection between the ball and the stem of a hip prosthesis is loaded until failure.

The Fatigue Test was made according to CeramTec test procedure AA 02 10 0807. The ball is placed on a conical bearing simulating the stem. The modular connection between the ball and the stem of a hip prosthesis is loaded with a sinusoidal axial force at 10 million cycles.

The Post-Fatigue Test was a compression test made under smooth load with a constant rate of 2mm/min according to ISO 7206-10 (ISO 7206-10: Implants for surgerv - Partial and total hip joint prostheses - Part 10: Determination of resistance to static load of femoral heads). The modular connection between the ball and the stem of a hip prosthesis is loaded until failure after the fatigue test.

The Rotational Stability Test or "torsion test" followed the test description according to the Ceramtec procedure VP-KU-0180. A modular fitting between ball and stem is subjected to frictional torsion until movement occurs.

The Pull-Off Test was made in compliance with the test description of the CeramTec procedure VP-KU-0210, but with 5 samples according to the FDA recommendations. This test corresponds to ISO 7206-10. The femoral head is pressed onto a taper using an axial force of 2 kN and pulled off axially using a loading rate of 1mm/min.

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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 Delta Heads can be considered as substantially equivalent to its predicate devices.

Mectacer Biolox Delta Heads 510(k)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-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.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medacta International SA % Mr. Adam Gross Director of Regulatory and Quality -Medacta USA 4725 Calle Quetzal Unit B Camarillo. California 93012

OCT - 7 2011

Re: K112115 Trade/Device Name: MectaCer Biolox Delta Heads 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: September 20, 2011 Received: September 21, 2011

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 contractly and i 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 not 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

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Page 2 – Mr. Adam Gross

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 forth in the quality systems (OS) 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/Reportal?roblem/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. Meller

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

12115

510(k) Number (if known):

Device Name: Mectacer Biolox Delta Heads

Indications for Use:

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 surqery: joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

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 ffice of Device Evaluation (ODE)

Whither fs Mym
(Division Sign Off)

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

K12115

Mectacer Biolox Dell July 22, 2011

Section 4 - Page 2 of 2

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.