The Tritanium® Peri-Apatite™ Acetabular Shell is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

The indications for use of the total hip replacement prostheses include:

Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous failed femoral head replacement, shell arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor bone quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Additional indications for use when using constrained liners: The device is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Additional indications for use when using modular dual mobility (MDM) liners: The device is indicated for use as a component of a total hip prosthesis and include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed;
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and
Dislocation risks

The MDM liners are intended for cementless use only. The acetabular shell is intended for cementless use only.

Device Description

The Tritanium® Peri-Apatite ™ acetabular shells are available in both solid backed and cluster screw-hole designs for cementless, biologic fixation. The Howmedica Osteonics Tritanium® Peri-Apatite™ Acetabular Shell consists of a hemispherical, metallic acetabular shell with a Tritanium® (CPTi) coating referred to as a Particle Sintered Foam (PSF) coating with an overlying Peri-Apatite coating (precipitated calcium phosphate coating). The Peri-Apating process is identical to that cleared in K971206 but to a greater thickness range of 35-75 microns. The Tritanium® CPTi PSF coating originally manufactured from material conforming to ASTM F67 was modified to conform to ASTM F1580. The dual coating (Peri-Apatite™ overlying the PSF coating) at the thickest specification met the definition of a porous coating per 21 CFR 888.3358 with no additional claims over biologic fixation. The dome hole plugs are optional devices which are available to seal the Howmedica Osteonics Tritanium® Acetabular Shells. The plugs are to be threaded into the dome holes of the shell.

The shells will be available in sizes 44-72 mm outside diameter (OD) in 2 mm increments. The acetabular shells are forged from Ti-6Al-4V alloy per ASTM F136; the Tritanium® coating is fabricated from Commercially Pure Titanium per ASTM F1580; and the Peri-Apatite™ coating is a precipitated calcium phosphate coating per ASTM F-1609.

The Tritanium® Peri-Apatite™ Acetabular Shells are compatible with polyethylene Trident® inserts, constrained liners and modular dual mobility liners. The subject shells have an identical insert locking mechanism to that employed with compatible Tritanium acetabular shell system predicates. All shells are single use devices. The outer surface of the acetabular shell has the identical geometry as the predicate Tritanium® Acetabular Shell System determined substantially equivalent via 510(k) K081171.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Tritanium® Peri-Apatite™ Acetabular Shell System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a medical device submission (510(k)) for substantial equivalence, not a detailed performance study with explicit numerical acceptance criteria and reported device performance values in the typical sense of a diagnostic or predictive algorithm.

However, we can infer the "acceptance criteria" as meeting the requirements of the referenced guidance documents and demonstrating substantial equivalence to predicate devices. The "reported device performance" is that it met these criteria.

Acceptance Criteria (Inferred)	Reported Device Performance
Conformance to ASTM F1580 (Commercially Pure Titanium)	The Tritanium® coating was modified to conform to ASTM F1580. Additional testing on the CPT Tritanium conforming to ASTM F1580 was performed, including static tensile, static shear, and shear fatigue bond strength.
Conformance to ASTM F1609 (Calcium Phosphate Coatings)	The Peri-Apatite™ coating is a precipitated calcium phosphate coating per ASTM F-1609.
Conformance to ASTM F136 (Ti-6Al-4V alloy)	The acetabular shells are forged from Ti-6Al-4V alloy per ASTM F136.
Meeting definition of porous coating per 21 CFR 888.3358	The dual coating/surface at the thickest specification met the definition of a porous coating per 21 CFR 888.3358 with no additional claims over biologic fixation.
Characterization per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement (28 April 1994)"	Non-clinical laboratory testing was performed as outlined in this guidance document for the underlying Tritanium surface. This included static tensile, static shear, and shear fatigue bond strength testing.
Characterization per "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants (February 20, 1997)"	All characterization parameters on the final dual coating/surface were provided according to this guidance. This included using NIST SRM 2910(a) as a comparator for X-ray diffraction, dissolution rate, and solubility product parameters. The dual coating/surface underwent additional characterization to demonstrate porosity at the thickest specification.
Mechanical Performance (Fatigue/Abrasion)	Four-point bend fatiguing, abrasion, and fatigue strength of the subject acetabular shell were performed. Third-body wear information was provided.
Substantial Equivalence to Predicate Devices	The conclusion explicitly states: "The Tritanium® Peri-Apatite™ Acetabular Shell System is substantially equivalent to the predicate devices identified in this premarket notification." "All of the observed results indicate that the subject Tritanium® Peri-Apatite™ Acetabular Shell System is substantially equivalent to devices currently cleared for marketing." The FDA's letter concurs with this determination.

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

This document describes a submission for a physical medical device (an acetabular shell system), not a software algorithm or AI device that would typically use "test sets" or "training sets" of patient data.

Sample Size for Test Set: Not applicable. The "test set" here refers to physical samples of the device and its materials, subjected to various mechanical and material property tests. The exact number of samples for each test (e.g., how many shells were fatigue tested) is not specified, but it would be sufficient to meet the requirements of the referenced ASTM standards and FDA guidance documents for device materials and mechanical performance.
Data Provenance: Not applicable in the context of patient data. The provenance for the testing is "non-clinical laboratory testing" performed by the manufacturer, Howmedica Osteonics Corp., in the USA (implied as they are a US company submitting to the FDA). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

This is not applicable to this type of device submission. "Ground truth" in this context is established by:

Engineering measurements (e.g., dimensions, material composition, mechanical properties) where the "truth" is the measured value against a standard specification.
Expert interpretation of those measurements by qualified engineers, material scientists, and regulatory affairs personnel within the manufacturing company, ensuring compliance with standards and guidance documents.
The FDA reviewers themselves act as experts evaluating the presented data against regulatory requirements.

There are no "experts" in the sense of clinicians establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" for a test set of patient data described here. The evaluation involves comparing test results of the physical device and its materials against predefined engineering and regulatory specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI devices where human readers interpret medical images or data. This submission is for an orthopedic implant.

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

No, a standalone performance study was not done. This concept is only applicable to AI/algorithm-based devices. The device described is a physical orthopedic implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's efficacy and safety claims (leading to substantial equivalence) is based on:

Material Specifications: Adherence to ASTM standards for various materials (F136, F67/F1580, F1609).
Mechanical Testing Results: Measurements of static tensile, static shear, shear fatigue bond strength, four-point bend fatiguing, abrasion, and fatigue strength, compared against established performance benchmarks in the relevant FDA guidance documents and presumably internal specifications.
Biocompatibility/Coating Characterization: X-ray diffraction, dissolution rate, solubility product parameters, and porosity measurements, compared against NIST standards (SRM 2910(a)) and FDA guidance for porous and HA-coated implants.
Substantial Equivalence to Predicate Devices: The ultimate "ground truth" for regulatory clearance is that the device is shown to be as safe and effective as legally marketed predicate devices, meaning that the differences do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. As stated earlier, this is not an AI/algorithm-based device, so there is no "training set" of data in the AI sense.
- One could loosely interpret "training" as the iterative design and testing process of the device leading up to the submission, where materials and designs may have been refined based on prior test results. However, this is not a formal "training set" as understood in machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. Since there is no "training set" in the AI sense, there's no ground truth to establish for it.

Summary

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APR 1 1 2011

510(k) Summary

Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430

K101072 p1/3

Contact Person

Sponsor

Karen Ariemma Project Manager, Regulatory Affairs/Regulatory Compliance Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5718

Date Prepared: April 8, 2011

Tritanium® Peri-Apatite™ Acetabular Shell System Proprietary Name:

Artificial Hip Replacement Components - Acetabular Common Name:

Classification Name:

21 CFR §888.3358: Hip joint metal/polymer/metal semi-constrained and porous-coated uncemented prosthesis

21 CFR §888.3310: Hip joint metal/polymer constrained cemented or uncemented prosthesis.

21 CFR §888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis:

21 CFR §888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

21 CFR §888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis

LPH, MEH, LZO, KWZ, LWJ and JDI Product Codes:

Legally Marketed Device to Which Substantial Equivalence is Claimed: Howmedica Osteonics Tritanium Acetabular Shell System: K081171 Howmedica Osteonics Vitalock Solid Back Acetabular Shell with Peri-Apatite: K971206 Landos Inc. Corail Stem: K953111 Aesculap BiContact Hip System with u-CaP K043079 Smith& Nephew, Smith & Nephew Hip Systems with HA Coating: K090982.

Device Description: The Tritanium® Peri-Apatite ™ acetabular shells are available in both solid backed and cluster screw-hole designs for cementless, biologic fixation. The Howmedica Osteonics Tritanium® Peri-Apatite™ Acetabular Shell consists of a hemispherical, metallic acetabular shell with a Tritanium® (CPTi) coating referred to as a Particle Sintered Foam (PSF) coating with an overlying Peri-Apatite coating (precipitated calcium phosphate coating). The Peri-Apating process is identical to that cleared in K971206 but to a greater thickness range of 35-75 microns. The Tritanium® CPTi PSF coating originally manufactured from material conforming to ASTM F67 was modified to conform to ASTM F1580. The dual coating (Peri-Apatite™ overlying the PSF coating) at

{1}------------------------------------------------

K101072 p 2/3

the thickest specification met the definition of a porous coating per 21 CFR 888.3358 with no additional claims over biologic fixation. The dome hole plugs are optional devices which are available to seal the Howmedica Osteonics Tritanium® Acetabular Shells. The plugs are to be threaded into the dome holes of the shell.

Intended Use: The Tritanium® Peri-Apatite™ Acetabular Shell is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

Indications:

The indications for use of the total hip replacement prostheses include:

1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous failed femoral head replacement, shell arthroplasty or other procedure. 2.
Clinical management problems where arthrodesis or alternative reconstructive techniques are 3. less likely to achieve satisfactory results.
Where bone stock is of poor bone quality or inadequate for other reconstructive techniques as 4. indicated by deficiencies of the acetabulum.

Additional indications for use when using modular dual mobility (MDM) liners: The device is indicated for use as a component of a total hip prosthesis and include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
1. Rheumatoid arthritis;
Correction of functional deformity; 3.
Revision procedures where other treatments or devices have failed; 4.
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with న్. head involvement that are unmanageable using other techniques; and
1. Dislocation risks

The MDM liners are intended for cementless use only. The acetabular shell is intended for cementless use only.

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K101072
r3/3

Summary of Technologies: The technology characteristics are the same basic principles as the predicates with minor differences occurring in the material of Tritanium underlying surface and the Peri-Apatite thickness.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. Non-clinical testing was provided as outlined in the FDA Guidance Document entitled "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement (28 April 1994)" for the underlying Tritanium surface which included additional testing on the CPT Tritanium conforming to ASTM F1580 in terms of static tensile, static shear and shear fatigue bond strength testing. The dual coating/surface was characterized per the FDA Guidance document entitled "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants (February 20, 1997)." All characterization parameters on the final dual coating/surface were provided. The NIST SRM 2910(a) material was used as a comparator for the Xray diffraction, dissolution rate and solubility product parameters. The dual coating/surface underwent additional characterization to demonstrate that the definition of porosity was met per 21 CFR 888.3358 at the thickest specification. Additionally, four-point bend fatiguing, abrasion, and fatigue strength of the subject acetabular shell were performed. Third body wear information was provided to address the theoretical risk. All of the observed results indicate that the subject Tritanium® Peri-Apatite™ Acetabular Shell System is substantially equivalent to devices currently cleared for marketing.

Clinical Testing: None provided as a basis for substantial equivalence.

Conclusion: The Tritanium® Peri-Apatite™ Acetabular Shell System is substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized eagle-like symbol. The symbol is composed of three angled lines that form the body and wings of the bird, with three curved lines below representing its legs or feet.

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

Howmedica Osteonics Corp. % Ms. Karen Ariemma, RAC Project Manager, Regulatory Affairs/ Regulatory Compliance 325 Corporate Drive Mahwah, New Jersey 07430

APR 1 1 2011

Re: K101072

Trade/Device Name: Tritanium® Peri-Apatite™ Acetabular Shell System (Tritanium® Peri-Apatite™ Acetabular Solid-backed Shell and Tritanium® Peri-Apatite™ Acetabular Cluster Screw-hole Shell) Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, MEH, LZO, KWZ, LWJ, JDI Dated: March 31, 2011 Received: April 04, 2011

Dear Ms. Ariemma:

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.

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Page 2 - Ms. Karen Ariemma, RAC

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 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,

Mark N. Melkerson

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

510(k) Number (if known): K101072

Device Name: Tritanium® Peri-Apatite™ Acetabular Shell System

Indications for Use:

The indications for use of the total hip replacement prostheses include:

Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, ﺘﺴ rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
Revision of previous failed femoral head replacement, shell arthroplasty or other procedure. 2.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less 3. likely to achieve satisfactory results.
Where bone stock is of poor bone quality or inadequate for other reconstructive techniques as 4. indicated by deficiencies of the acetabulum.

Additional indications for use when using modular dual mobility (MDM) liners: The device is indicated for use as a component of a total hip prosthesis and include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1.
Rheumatoid arthritis; 2.
Correction of functional deformity; 3.
Revision procedures where other treatments or devices have failed; 4.
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with న్.
head involvement that are unmanageable using other techniques; and
Dislocation risks 6.

The MDM liners are intended for cementless use only. The acetabular shell is intended for cementless use only.

Over-The-Counter Use Prescription Use . X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101072

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.