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 (NIDJD) 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 Description

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty.

The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs

The subject devices are line extensions to the previously cleared predicate systems to add 42mm OD shells and additional 22mm, 32mm, and 36mm ID elevated liners. The subject 32mm and 36mm liners are identical to the previously cleared devices; no changes have been made except for the additional sizes. The subject 22mm liner has been modified to include a poly-relief ring above the scallops. The subject 42mm shells have been modified so that they will not accept the option screw hole plugs.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device (hip prosthesis components) and as such, it does not detail acceptance criteria and a study in the same way one would for a diagnostic AI device. Instead, it outlines non-clinical performance testing to demonstrate substantial equivalence to predicate devices.

Here's an interpretation based on the document, addressing the requested points where applicable, and noting when the information is not present for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside performance metrics in the format typically seen for AI device validation. Instead, it states that "the observed test results exceeded all acceptance criteria." The acceptance criteria would likely be defined by relevant ISO standards or internal Zimmer specifications for mechanical and wear performance of orthopedic implants.

Performance Test	Acceptance Criteria	Reported Device Performance
Wear Performance Analysis	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.
Anatomic Fatigue Test	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.
Durability and Backside Wear Analysis	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.
Lever-Out Strength Test	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.
Push-Out Strength Test	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.
Torque-Out Strength Test	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.
Compatibility in the MR Environment Test	(Implicitly: Meet/exceed predicate or defined standard)	Functioned as intended and exceeded all acceptance criteria.

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

Test Set Sample Size: The document does not specify the exact sample sizes (number of devices, test repetitions) for each non-clinical test. This information would typically be detailed in the full test reports, not in this summary document.
Data Provenance: The data is from non-clinical (laboratory) testing conducted by Zimmer, Inc. or its contracted labs. It is not human subject data from a specific country or retrospective/prospective in the medical sense.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This requirement is not applicable to this type of non-clinical device submission. Ground truth for mechanical and wear testing is typically established through engineering and metrology standards, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., image interpretation), not for non-clinical mechanical testing.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a non-clinical evaluation of medical device components (hip prosthesis). MRMC studies are relevant for diagnostic AI devices assessing human reader performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI algorithm. The performance described is "standalone" in the sense that the device components were tested in a controlled laboratory environment without human interaction during the test itself, but it's not an "algorithm-only" evaluation.

7. Type of Ground Truth Used

The ground truth for this device's performance relies on:

Engineering specifications and design requirements.
Industry standards (e.g., ISO standards for orthopedic implants).
Performance data of legally marketed predicate devices, which serve as the benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of medical device submission.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the word "Zimmer" written in a stylized font. Above the word, there is a circular emblem containing a stylized letter "Z" with arrows pointing in opposite directions within the circle. The logo appears to be for the Zimmer company.

K101229

Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Names:

Common Name:

Classification Names and References:

Predicate Devices:

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

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

DEC - 3 20.J

Rebecca Brooks Regulatory Affairs Specialist Telephone: 574.371.8033 Fax: 574.372.4605

July 12, 2010

Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Continuum™ Acetabular System Trilogy Integrated Taper (IT) Acetabular System

Total Hip Prosthesis

LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented; 21 CFR § 888.3358.

JDI - Prosthesis, hip. semi-constrained, metal/polymer, cemented; 21 CFR § 888.3350.

LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented; 21 CFR § 888.3353.

Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer Inc., K091508. cleared September 11, 2009.

Longevity® IT Highly Crosslinked Polyethylene Elevated Liners manufactured by Zimmer Inc., K093846, cleared 04 February 2010.

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Kiol229

Device Descriptions:

Intended Use:

Comparison to Predicate Devices:

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty.

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

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners and the Continuum and Trilogy IT Acetabular Systems Shells are packaged, manufactured, and sterilized using equivalent materials and processes as their predicates. The subject device also has the same intended use as the predicate.

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Page 3 July 12, 2010

K101229

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Non-clinical testing was conducted to demonstrate that the subject device performed as intented and met all acceptance criteria. Specific non-clinical testing that was completed includes:

· Wear Performance Analysis
· Anatomic Fatigue Test
Durability and Backside Wear Analysis
· Lever-Out Strength Test
· Push-Out Strength Test
· Torque-Out Strength Test
· Compatibility in the MR Environment Test

Testing was conducted on the subject devices and compared to the predicate systems. The subject devices functioned as intended and the observed test results exceeded all acceptance criteria. Additionally, an evaluation of the device design and geometry was done, which demonstrated that the Zimmer Longevity IT Highly Crosslinked Polyethylene Elevated Liners and the Continuum and Trilogy IT Acetabular Systems Shells meet performance requirements and are as safe and effective as its predicates. This information and testing data forms the basis for a determination of substantial equivalence.

Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Zimmer, Inc. % Ms. Rebecca Brooks Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708

DEC - 3 2010

Re: K101229

Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene Elevated Liners. Continuum™ Acetabular System, Trilogy® Integrated Taper (IT) Acetabular System 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: November 5, 2010 Received: November 8, 2010

Dear Ms. Brooks:

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. Rebecca Brooks

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 vours.

Sincerely yours,

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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KID1229

Indications for Use

DEC - 3 2010

510(k) Number (if known):

Device Name:

Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Continuum™ and Trilogy® IT Acetabular Systems Shells

Indications for Use:

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

DEC - 3 2010

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line -- Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Spata for mxn

(Dicision Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101229

Page 1 of 1

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.