Noninflammatory degenerative joint disease incuding osteoarthritis and avascular necrosis:
Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup);
Correction of functional deformity:
Revision procedures where other treatments or devices have failed; and,
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

The Tritanium Non-Modular Shell is intended for cementless use, while the X30 All-Poly Insert is intended for cemented use only.

Device Description

The Tritanium Non-Modular Shell described in this Traditional 510(k) submission consist of single use devices which is intended for cementless fixation within the prepared acetabulum. The X3® All-Poly Insert, also single use devices, are intended to mate only with the Tritanium® Non-Modular Shell and must be fixed with bone cement within the metal shell.

The assembled acetabulum component is used in conjunction with any appropriately sized Howmedica Osteonics stem with a compatible head size, excluding bi-polar and uni-polar heads, to that of the respective insert, to achieve total reconstructive replacement of the hip joint.

AI/ML Overview

The provided text is a 510(k) summary for the Tritanium® Non-Modular Shell & X3® All-Poly Insert, which are artificial hip replacement components. It describes the device, its intended use and indications, and states its substantial equivalence to predicate devices.

However, this document does not contain information about the acceptance criteria for a device's performance, nor does it describe any study (including clinical or standalone performance studies) that proves the device meets such criteria.

The 510(k) process for this type of device (hip replacement components) typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish performance metrics like sensitivity, specificity, or reader improvement with AI assistance. Instead, mechanical testing, material characterization, and sometimes animal studies are used to support safety and effectiveness and substantial equivalence.

Therefore, I cannot fulfill the request to provide the acceptance criteria and a study proving the device meets them, as the provided document does not contain this information.

Specifically, the following points cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: Not present.
Sample size used for the test set and the data provenance: Not applicable/Not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present.
Adjudication method for the test set: Not applicable/Not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/Not present. This device is not an AI/software device that would typically undergo such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not present. This device is a physical implant, not an algorithm.
The type of ground truth used: Not applicable/Not present.
The sample size for the training set: Not applicable/Not present.
How the ground truth for the training set was established: Not applicable/Not present.

Summary

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K090897

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510(k) Summary of Safety and Effectiveness Tritanium® Non-Modular Shell & X3® All-Poly Insert

OCT 2 3 2009

Proprietary Name:	Tritanium® Non-Modular Shell & X3® All-Poly Insert
Common Name:	Artificial Hip Replacement Components- Acetabular
Classification Name/Reference:	Hip joint metal/polymer/metal semi constrained porouscoated uncemented prosthesis
	Hip joint metal/polymer semi-constrained cementedprosthesis.
	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis.
Device Product Code:	87 LPH, 87LZO, 87MEH, 87JDI
Proposed Regulatory Class:	Class II
For Information contact:	Avital Merl-MarguliesRegulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365Fax: (201) 831-3365
Date Summary Prepared:	October 19, 2009

Description:

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090897

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Intended Use:

The Tritanium® Non-Modular Shell & X30 All-Poly Insert are a sterile, single use device intended for use in both primary and revision applications.

Indications:

1. Noninflammatory degenerative joint disease incuding osteoarthritis and avascular necrosis:
1. Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup);
1. Correction of functional deformity:
1. Revision procedures where other treatments or devices have failed; and,
1. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

The Tritanium Non-Modular Shell is intended for cementless use, while the X30 All-Poly Insert is intended for cemented use only.

Substantial Equivalence:

The Tritanium® Non-Modular Shell & X3® All-Poly Insert is substantially equivalent to other commercially available acetabular systems in regards to intended use, design features, materials, and operational principles. The following devices are examples of predicate systems: TridentTM Porous Titanium Acetabular Shell, Zimmer Trabecular MetalTM Acetabular Revision System, Trident® Constrained Acetabular Insert, & Trident® Large Diameter Acetabular Inserts.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle head in profile, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle head.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

OCT 2 3 2009

Re: K090897

Trade/Device Name: Tritanium Non-Modular Shell & X3 All-Poly Insert Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, MEH, JDI Dated: October 19, 2009 Received: October 21, 2009

Dear Ms. Merl-Margulies:

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.

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 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.

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Page 2 - Ms. Avital Merl-Margulies

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/ResourcesforYou/Industry/default.htm.

Sincerely yours, Mark N. Melke

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): K090897

Device Name: Tritanium® Non-Modular Shell & X3® All-Poly Insert

Indications for Use:

1. Noninflammatory degenerative joint disease incuding osteoarthritis and avascular necrosis;
1. Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup);
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and,
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur రా with head involvement that are unmanageable using other techniques

The Tritanium Non-Modular Shell is intended for cementless use, while the X3® All-Poly Insert is intended for cemented use only in both primary and revision applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oosta 2 for MXM
(Review Signature)

Division Sier Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K090897

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.