The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

Device Description

The ZMR Hip System is a modular hip system for cementless revision hip arthroplasty. The stem assembly is manufactured from Tivanium® Ti-6Al-4V Alloy and utilizes modular junctions between the head and neck, and the metaphyseal body and diaphyseal stem segments. A variety of body and stem components are provided to achieve fixation and restore joint kinematics. The femoral stem assembly contains a 12/14 taper designed to mate with the corresponding femoral head component.

The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semiconstrained acetabular systems and acetabular augments, restrictors, and cages. Both the indications for use provided below and the indications for use provided with those devices combined with the ZMR Hip System must be followed.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the ZMR® Hip System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than strictly meeting acceptance criteria through a study with performance metrics in the way a new, novel AI device might.

Therefore, the requested information components related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable in their typical sense to this device and its submission. The document explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that the regulatory pathway chosen did not require a study demonstrating quantitative performance against predefined acceptance criteria from clinical data.

However, I can extract and interpret the available information regarding the "study" (non-clinical performance testing) and substantial equivalence.

Summary of Acceptance Criteria and Device Performance (Interpreted for a Predicate-Based Submission)

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Non-Clinical)
Intended Use Equivalence: The device has the same intended clinical purpose.	The ZMR Hip System is indicated for cementless revision hip arthroplasty, similar to predicate devices.
Materials Equivalence: The device uses similar or identical materials.	Manufactured from Tivanium® Ti-6Al-4V Alloy, comparable to predicate devices.
Sterility Equivalence: The device maintains similar sterility characteristics.	Similar sterility characteristics to predicate devices.
Performance Characteristics Equivalence (Non-Clinical): The device demonstrates comparable mechanical and functional performance to predicate devices.	Fretting Fatigue Testing: Results showed the device is safe and effective and substantially equivalent.
	Range of Motion Analyses: Results showed the device is safe and effective and substantially equivalent.
Substantial Equivalence to Predicate(s): The totality of evidence demonstrates the device is as safe and effective as a legally marketed predicate device.	The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. FDA concurred with this determination.

Explanation of Applicability for Other Requested Information:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human-based test set in the traditional sense was used. The "performance data" was non-clinical lab testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No human-based clinical test set requiring expert ground truth was performed for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human-based clinical test set requiring adjudication was performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a hip implant, not an AI diagnostic device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hip implant, not an AI algorithm. Its performance is evaluated through material properties and mechanical testing, not algorithm-only performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical testing: The "ground truth" (or reference standard) would be established by engineering standards, material specifications, and validated mechanical testing protocols, comparing the ZMR Hip System's performance to those of the predicate devices under controlled lab conditions.
The sample size for the training set:
- Not Applicable. No training set in the context of machine learning or AI was used.
How the ground truth for the training set was established:
- Not Applicable. No training set for AI was used.

Conclusion based on the document:

The ZMR® Hip System received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices. This was primarily achieved through non-clinical (lab) performance testing, specifically Fretting Fatigue Testing and Range of Motion Analyses. These tests demonstrated that the device is "safe and effective and substantially equivalent" to the predicate devices in terms of intended use, materials, sterility, and performance characteristics. The document explicitly states that "Clinical data and conclusions were not needed for this device," meaning no human clinical study was required to establish performance against specific acceptance criteria in a clinical setting.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.

KII3296

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

SEP 14 2012

Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Product Code / Device:

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

Daniel J. Williman Associate Project Manager, Regulatory Affairs Telephone: 574-371-8065 Fax: (574) 372-4605

September 14, 2012

ZMR® Hip System

LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

LWJ - Prosthesis, hip, semi-constrained, metal/polymer, uncemented

JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented

KWZ - Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Regulation Number / Description:

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

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

Page 1 of 4

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Predicate Device:

K113296

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

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

21 CFR § 888.3310 – Hip joint metal/polymer constrained, cemented or uncemented prosthesis

ZMR Hip System - Revision Taper, manufactured by Zimmer, Inc, K992667, cleared October 27, 1999

ZMR Hip System - Porous Revision, manufactured by Zimmer, Inc, K994286, cleared March 10, 2000

ZMR Hip System - XL, manufactured by Zimmer, Inc, K031572, cleared June 24, 2003

Taperloc Complete System and Taperloc Complete Microplasty System, manufactured by Biomet, Inc., K101086, cleared September 3, 2010 and K110400, cleared September 30, 2011

DJO Surgical Revision Femoral Hip System, manufactured by Encore Medical, L.P., K092331, cleared March 3, 2010

Trabecular Metal Acetabular Augments, manufactured by Zimmer Trabecular Metal Technology, K061067, cleared May 25, 2006 and K042871, cleared December 21, 2004

Hedrocel Acetabular Restrictor, manufactured by Implex Corp., K962468, cleared February 3, 1997

Zimmer Trabecular Metal Acetabular Revision System Cage, manufactured by Zimmer, Inc, K061226, cleared August 2, 2006.

Page 2 of 4

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Kil3296

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

Device Description:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

The ZMR Hip System is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate device(s).

Non-Clinical Performance and Conclusions:

The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included Fretting Fatigue Testing and Range of Motion Analyses.

Page 3 of 4

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Image /page/3/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font.

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

Clinical Performance and Conclusions:

. .

Clinical data and conclusions were not needed for this device.

Page 4 of 4

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

SEP 14 2012

Zimmer, Inc. % Mr. Daniel J. Williman Associated Project Manager Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K113296 Trade/Device Name: ZMR® Hip 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, LZO, LWJ, JDI, KWZ Dated: September 10, 2012 Received: September 12, 2012

Dear Mr. Williman:

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

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Page 2 – Mr. Daniel J. Williman

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 M Milliman

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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K11 3296

Indications for Use

510(k) Number (if known): K113296

Device Name:

ZMR® Hip System

Indications for Use:

signature

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113296

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)

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.