Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,

The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation.

The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Device Description

The Initia Total Hip System is comprised of femoral stems, Co-Cr femoral heads, acetabular shells, an apical hole plug, bone screws and crosslinked polyethylene acetabular liners.

The BIOCERAM AZUL® ceramic heads are zirconia toughened alumina (ZTA) ceramic femoral heads compatible with the femoral stems, acetabular shells and acetabular liners of the Initia Total Hip System.

The femoral stem is a monoblock wedge tapered design. It is manufactured from forged titanium alloy complying with ASTM F136 and ASTM F620 and is coated with a plasma spray of commercially pure titanium complying with ASTM F1580. The stem is offered in 19 stem sizes which include both standard and high offset neck options, for a total of 38 offerings.

The Co-Cr femoral head is manufactured from wrought Co-Cr complying with ASTM F1537. The head has a 12/14 taper bore and is available in outer diameters of 22, 26, 28, 32, 36, 40 and 44 mm. Each head diameter is available in multiple offset options.

The acetabular shell is also made from titanium alloy complying with ASTM F136. The acetabular shell is available in outer diameters ranging from 40 mm to 74 mm in 2 mm increments. The outer surface of the shell is coated with a plasma spray of commercially pure titanium complying with ASTM F1580. The acetabular shell is offered in 0 hole, 3 hole, and multi-hole configurations. Self-tapping acetabular bone screws can be used for initial shell fixation. The screws are made from titanium alloy complying with ASTM F136. Bone screws are available in a 6.5 mm diameter and lengths from 15 to 60 mm in 5 mm increments. An apical hole plug, manufactured from titanium alloy complying with ASTM F136, is available to close the apical hole on the acetabular shell.

The acetabular liner is made from crosslinked ultra high molecular weight polyethylene (UHMWPE) complying with ASTM F648 and ASTM F2565. The polyethylene liner is offered in inner diameters of 22, 26, 28, 32, 36, 40 and 44 mm with outer diameters to fit the 40 - 74 mm acetabular shells. The liner is offered in 4 configurations: standard (STD), standard with offset (STD HO), elevated rim (MX), and elevated rim with offset (MX HO). The liner mates with the shell using a circumferential locking feature that is integrated into the liner to prevent disassociation. The locking feature mates with a circular groove machined into the shell. The liner also possesses anti-rotation tabs that mate with scallops in the shell.

The BIOCERAM AZUL® ceramic head is manufactured from high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. The head has a 12/14 taper bore and is available in outer diameters of 28, 32, 36, 40 and 44 mm. There are 3 offsets (-3.5, +0, +3.5 mm) for the 28 mm size. There are 4 offsets (-3.5, +0, +3.5, +7 mm) for the 32 to 44 mm sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Initia Total Hip System & BIOCERAM AZUL® HEAD." This document focuses on the substantial equivalence of the new device to existing predicate devices, primarily through mechanical testing and material characterization, rather than studies involving human or expert evaluation of performance in a diagnostic or clinical decision-making context.

Therefore, many of the requested categories related to expert-based ground truth, multi-reader multi-case studies, and human performance improvement are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the devices met "pre-determined acceptance criteria" for various mechanical tests. Specific numerical acceptance criteria values are not provided in this summary. The reported performance is generally stated as "met pre-determined acceptance criteria."

Test Type	Acceptance Criteria	Reported Device Performance
Femoral Stem Neck Fatigue	Pre-determined	Met acceptance criteria
Femoral Stem Fatigue	Pre-determined	Met acceptance criteria
Co-Cr Femoral Head / Femoral Stem Taper Axial Pull-Off	Pre-determined	Met acceptance criteria
Fretting Corrosion (Co-Cr femoral head)	Pre-determined	Met acceptance criteria
Acetabular Shell / Acetabular Liner Push-Out	Pre-determined	Met acceptance criteria
Acetabular Shell / Acetabular Liner Lever-Out	Pre-determined	Met acceptance criteria
Acetabular Shell / Acetabular Liner Torque-Out	Pre-determined	Met acceptance criteria
Hip Simulator Wear (Co-Cr femoral head)	Pre-determined	Met acceptance criteria
Mode 3 (w/ roughened femoral head) Hip Simulator Wear	Pre-determined	Met acceptance criteria
Wear Particle Analyses (Co-Cr femoral head)	Pre-determined	Met acceptance criteria
Impingement	Pre-determined	Met acceptance criteria
Bone Screw Torsional Strength	Pre-determined	Met acceptance criteria
Bone Screw Insertion and Removal Torque	Pre-determined	Met acceptance criteria
Bone Screw Pull-Out	Pre-determined	Met acceptance criteria
Total Hip Range of Motion	Pre-determined	Met acceptance criteria
Femoral Stem Coating Characterization & Performance (Static Shear, Static Tensile, Shear Fatigue, Abrasion Resistance)	Pre-determined	Met acceptance criteria
Acetabular Shell Coating Characterization & Performance (Static Shear, Static Tensile, Shear Fatigue, Abrasion Resistance)	Pre-determined	Met acceptance criteria
Crosslinked UHMWPE liner material characterization (aged/unaged vs. predicate)	Pre-determined	Met acceptance criteria
Bacterial Endotoxin Testing	20 EU/device	Met endotoxin limit
BIOCERAM AZUL® Ceramic Heads: Static Burst Strength	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Fatigue	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Post-Fatigue Burst Strength	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Axial Pull-Off	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Fretting Corrosion	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Hip Simulator Wear	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Mode 3 (w/ roughened ceramic head) Hip Simulator Wear	Pre-determined	Met acceptance criteria
BIOCERAM AZUL® Ceramic Heads: Wear Particle Analyses	Pre-determined	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide specific sample sizes for the mechanical tests. The data provenance is implied to be laboratory testing conducted by the manufacturer, KYOCERA Medical Corporation. There is no mention of country of origin of the data explicitly, nor whether it was retrospective or prospective in the context of clinical data, as this was not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. This submission is based on mechanical and material engineering testing, not on expert clinical judgment for a diagnostic or AI-based performance evaluation.

4. Adjudication Method for the Test Set:

Not Applicable. As there was no expert review or clinical assessment, no adjudication method was used.

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:

Not Applicable. This submission does not involve an AI device or human-in-the-loop performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established by engineering standards and pre-determined mechanical and material acceptance criteria. For example, the Bacterial Endotoxin Testing had a specific limit of 20EU/device. For other tests, the "pre-determined acceptance criteria" serve as the ground truth against which the device performance was measured.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. Not an AI model.

In summary, this regulatory submission primarily relies on non-clinical performance data (mechanical, material, and biocompatibility testing) to demonstrate substantial equivalence to predicate devices, without involving clinical studies or AI algorithm evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

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

November 1, 2016

KYOCERA Medical Corporation Ms. Cheryl Hastings Official Correspondent Uemura Nissei Bldg., 3-3-31 Miyahara Yodogawa-ku Osaka, 532-0003 Japan

Re: K160895 Trade/Device Name: Initia Total Hip System & BIOCERAM AZUL® HEAD 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, LPH Dated: September 28, 2016 Received: September 29, 2016

Dear Ms. Cheryl Hastings:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K160895 510(k) Number (if known):

Device Name: Initia Total Hip System

Indications for Use:

The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
-Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
-Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,

The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Page 1 of 2

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K160895 510(k) Number (if known): _

Device Name: BIOCERAM AZUL HEAD

Indications for Use:

The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
-Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Page 2 of 2

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510(k) Summary

PREPARED:	October 26, 2016
510(k) SPONSOR:	KYOCERA Medical CorporationUemura Nissei Bldg., 3-3-31 MiyaharaYodogawa-kuOsaka, 532-0003 JapanPhone :+81-6-6350-1036Fax :+81-6-6350-5736
CONTACT PERSON:	Masato AtsumiSenior Manager of Regulatory Affairs DepartmentKYOCERA Medical CorporationUemura Nissei Bldg., 3-3-31 MiyaharaYodogawa-kuOsaka, 532-0003 JapanPhone :+81-6-6350-1493Fax :+81-6-6350-5752
TRADE NAMES:	Initia Total Hip SystemBIOCERAM AZUL HEAD
COMMON NAMES:	Total Hip SystemModular Ceramic Femoral Head
CLASSIFICATIONand CLASS:	21 CFR 888.3353 Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncementedprosthesis, Class II21 CFR 888.3358 Hip joint metal/polymer/metalsemi-constrained porous-coated uncemented prosthesis,Class II
PRODUCT CODES:	LZO, LPH

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PREDICATE DEVICES:

· Biomet, Taperloc® 12/14 Taper Femoral Components (K043537)
· Howmedica Osteonics Accolade II Hip Stem (K120578)
· DePuy, Focus Total Hip System, Articul/eze Femoral Heads and Modular M Heads (K883460, K980513, K060031)
Biomet, Porous Plasma Spray (PPS) Ringloc + Acetabular System (K093235)
· DePuy Orthopaedics Pinnacle Acetabular System (K000306)
· Biomet ArcomXL Polyethylene Liners (K042051)
· DePuy, DePuy Pinnacle® AltrX™ Acetabular Liners (K072963, K102423)
· Medacta International Mectacer Biolox Delta Heads (K112115)
· Smith & Nephew, Reflection® Cross-linked UHMWPE Acetabular Components (K932755, K991026, K002747, K013658)
· Encore Orthopedics, 6.5 mm Cancellous Bone Screw (K931665)
· Howmedica Osteonics, Trident® Hip System (K033716)
· Howmedica Osteonics, Crossfire™ System 12® Acetabular Inserts (K993352)
· Howmedica Corp., Howmedica ® Acetabular Comp Pack/Manuf Meth (K934060)

DEVICE DESCRIPTION:

The Initia Total Hip System is comprised of femoral stems, Co-Cr femoral heads, acetabular shells, an apical hole plug, bone screws and crosslinked polyethylene acetabular liners.

The BIOCERAM AZUL® ceramic heads are zirconia toughened alumina (ZTA) ceramic femoral heads compatible with the femoral stems, acetabular shells and acetabular liners of the Initia Total Hip System.

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fixation. The screws are made from titanium alloy complying with ASTM F136. Bone screws are available in a 6.5 mm diameter and lengths from 15 to 60 mm in 5 mm increments. An apical hole plug, manufactured from titanium alloy complying with ASTM F136, is available to close the apical hole on the acetabular shell.

INDICATIONS FOR USE:

The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,

The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation.

The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:

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Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

The Initia Total Hip System and the BIOCERAM AZUL® ceramic heads are substantially equivalent to the predicate devices based on similarities in intended use, indications for use, materials, design, sizing and mechanical strength.

PERFORMANCE DATA:

Mechanical testing confirmed that the Initia Total Hip System met pre-determined acceptance criteria for femoral stem neck fatigue, femoral stem fatigue, Co-Cr femoral head / femoral stem taper axial pull-off, fretting corrosion, acetabular shell / acetabular liner push-out, lever-out and torque-out, hip simulator wear, Mode 3 (with a roughened femoral head) hip simulator wear, wear particle analyses, impingement, bone screw torsional strength, insertion and removal torque and pull-out, and total hip range of motion.

Characterization testing included femoral stem and acetabular shell coating characterization and performance testing (static shear, static tensile, shear fatigue, abrasion resistance), and characterization of the crosslinked UHMWPE liner material in aged and unaged conditions as compared to predicate devices.

Biocompatibility testing was also conducted. Bacterial Endotoxin Testing was performed and the endotoxin limit of 20EU/device was met.

The BIOCERAM AZUL® ceramic heads met pre-determined acceptance criteria for static burst strength, fatigue, post-fatigue burst strength, axial pull-off, fretting corrosion, hip simulator wear, Mode 3 (with a roughened ceramic head) hip simulator wear and wear particle analyses.

CLINICAL TESTING:

Clinical testing was not required for determining substantial equivalence with the predicate devices.

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.