Continuum and Trilogy Integrated Taper (IT) Acetabular Systems

K151448 · Zimmer, Inc. · LPH · Aug 13, 2015 · Orthopedic

Device Facts

• Record ID: K151448
• Device Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NID) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The system is intended for use either with or without bone cement in total hip arthroplasty.

Device Story

Modular acetabular cup system for total hip arthroplasty; replaces damaged hip joint; achieves fixation to bone with or without bone cement. Components include porous-coated shells, dome/screw hole plugs, and highly cross-linked polyethylene (HXPE) liners. Shells accommodate Tivanium alloy screws for additional fixation in deficient bone stock. Used by orthopedic surgeons in clinical/surgical settings. Subject of labeling modification to include MR Conditional status and safety information per FDA guidance for passive implants.

Clinical Evidence

No clinical data required. Bench testing performed to evaluate compatibility in the MR environment per FDA guidance.

Technological Characteristics

Modular acetabular system; porous-coated shells; highly cross-linked polyethylene (HXPE) liners; Tivanium alloy screws. Passive implant; MR Conditional. No software or electronic components.

Indications for Use

Indicated for primary or revision total hip arthroplasty in skeletally mature individuals with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant).

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

• Continuum and Trilogy Integrated Taper (IT) Acetabular Systems (K091508)
• Longevity IT Highly Crosslinked Polyethylene Elevated Liners (K093846)
• Longevity Integrated Taper (IT) Highly Crosslinked Polyethylene Elevated Liners, Continuum and Trilogy Integrated Taper (IT) Acetabular System Shells (K101229)
• Continuum and Trilogy Integrated Taper Highly Crosslinked Polyethylene Elevated, Offset, & Oblique Liners (K103662)

Submission Summary (Full Text)

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

August 13, 2015

Zimmer, Inc. Mr. Paul Hardy Specialist. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K151448

Trade/Device Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems 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, JDI, LZO Dated: June 12, 2015 Received: June 15, 2015

Dear Mr. Hardy:

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] 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

510(k) Number (if known)

K151448 (page 1/1)

Device Name

Continuum and Trilogy Integrated Taper (IT) Acetabular systems

Indications for Use (Describe)

The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NID) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

Type of Use (Select one or both, as applicable)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in blue. The logo is simple and modern, with a focus on the company's name and a distinctive initial.

P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131

## Summary of Safety and Effectiveness Sponsor: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Contact Person: Paul Hardy Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone] August 11, 2015 Date: Trade Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems including: Continuum IT and Trilogy IT Shells Longevity IT Highly Crosslinked Polyethylene Neutral Liners Longevity IT Highly Crosslinked Polyethylene Elevated Liners Product Codes / Device: LPH, JDI, LZO Regulation Number / Description: 21 CFR § 888.3358- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 21 CFR § 888.3350- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 21 CFR § 888.3353- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous. Uncemented Predicate Devices: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer, K091508, cleared September 11, 2009 Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K093846, cleared February 4, 2010

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| | Longevity Integrated Taper (IT) Highly Crosslinked<br>Polyethylene Elevated Liners, Continuum and<br>Trilogy Integrated Taper (IT) Acetabular System<br>Shells, manufactured by Zimmer, K101229, cleared<br>December 3, 2010 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Continuum and Trilogy Integrated Taper Highly<br>Crosslinked Polyethylene Elevated, Offset, &<br>Oblique Liners, manufactured by Zimmer,<br>K103662, cleared April 15, 2011 |
| Device Description: | The Continuum and Trilogy IT Acetabular Systems<br>are modular acetabular cup systems intended to<br>replace a hip joint and designed to achieve fixation<br>to bone either with or without bone cement. The<br>systems consist of porous coated shells, optional<br>dome and screw hole plugs, and highly cross-linked<br>polyethylene (HXPE) liners. The shells with screw<br>holes permit the use of previously cleared Tivanium<br>alloy screws to provide additional fixation and<br>security, particularly in those cases where<br>acetabular bone stock is deficient. The dome and<br>screw hole plugs may be placed by the surgeon into<br>any unused holes in the shell. |
| Intended Use: | The system is indicated for primary or revision<br>surgery in skeletally mature individuals for<br>rehabilitating hips damaged as a result of<br>noninflammatory degenerative joint disease<br>(NIDJD) or its composite diagnoses of<br>osteoarthritis, avascular necrosis, protrusio<br>acetabuli, traumatic arthritis, slipped capital<br>epiphysis, fused hip, fracture of the pelvis, and<br>diastrophic variant. The system is intended for use<br>either with or without bone cement in total hip<br>arthroplasty. |
| Comparison to Predicate Device: | This submission is for a labeling modification. The<br>labeling modification consists of the addition of<br>Magnetic Resonance Imaging (MRI) compatibility<br>information to the Package Insert, and the<br>application of the "MR Conditional" symbol on the<br>package label. |
| Performance Data (Nonclinical | Non-Clinical Performance and Conclusions: |

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and/or Clinical):

The Continuum and Trilogy IT Acetabular Systems have been evaluated for compatibility in the MR environment per Guidance for Industry and FDA Staff,"Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Based upon the results, the subject device is recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.