TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT

K090897 · Howmedica Osteonics Corp. · LPH · Oct 23, 2009 · Orthopedic

Device Facts

• Record ID: K090897
• Device Name: TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
• Applicant: Howmedica Osteonics Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tritanium® Non-Modular Shell & X3® 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; 2. Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup); 3. Correction of functional deformity; 4. 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 X3® All-Poly Insert is intended for cemented use only in both primary and revision applications.

Device Story

Acetabular hip replacement system consisting of Tritanium® Non-Modular Shell and X3® All-Poly Insert. Shell designed for cementless fixation into prepared acetabulum; insert requires bone cement for fixation within shell. Used in total hip arthroplasty in conjunction with compatible Howmedica Osteonics femoral stems and heads. Intended for primary and revision procedures. Operated by orthopedic surgeons in clinical/OR settings. Provides structural reconstruction of hip joint to restore function and mobility in patients with degenerative disease or fractures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Acetabular shell (Tritanium) and polymer insert (X3). Shell designed for cementless fixation; insert designed for cemented fixation. Single-use, sterile components.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (nonunion, femoral neck, trochanteric) requiring revision or primary hip replacement.

Regulatory Classification

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.

Predicate Devices

• TridentTM Porous Titanium Acetabular Shell
• Zimmer Trabecular MetalTM Acetabular Revision System
• Trident® Constrained Acetabular Insert
• Trident® Large Diameter Acetabular Inserts

Submission Summary (Full Text)

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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 porous<br>coated uncemented prosthesis |
| | Hip joint metal/polymer semi-constrained cemented<br>prosthesis. |
| | Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis. |
| Device Product Code: | 87 LPH, 87LZO, 87MEH, 87JDI |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Avital Merl-Margulies<br>Regulatory Affairs Associate<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | October 19, 2009 |

# 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.

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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:
- 2. Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup);
- 3. Correction of functional deformity:
- 4. Revision procedures where other treatments or devices have failed; and,
- 5. 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 [phone] or [phone] 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;
- 2. Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup);
- 3. Correction of functional deformity;
- 4. 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