ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 by ZIMMER, INC.

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

Like its predicates, the ZMR® Hip System-XL prosthesis is a modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a head/neck junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal "body," a distal stem, and a compression nut.

AI/ML Overview

The provided text describes a Special 510(k) for a device modification of the ZMR® Hip System-XL. The information primarily focuses on the device's regulatory approval based on its substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the typical sense of clinical or technical performance metrics.

Therefore, many of the requested elements for a comprehensive description of acceptance criteria and a study proving device performance (like specific performance metrics, sample sizes for test sets, expert involvement, MRMC studies, standalone performance, and detailed ground truth establishment) are not present in this regulatory document.

However, I can extract the available information and indicate where details are missing based on the document.

Acceptance Criteria and Device Performance

Based on the provided document, the "acceptance criteria" appear to be related to demonstrating substantial equivalence to predicate devices under the 510(k) pathway, specifically concerning safety and effectiveness. The "device performance" is primarily assessed through non-clinical testing to show this equivalence.

Acceptance Criteria Category	Specific Criteria (Inferred from document)	Reported Device Performance
Intended Use	The modified device must maintain the same intended use as the predicate.	The modifications "change neither the intended use" of the device.
Fundamental Scientific Technology	The modified device must utilize the same fundamental scientific technology as the predicate.	The modifications "change neither... the fundamental scientific technology of the device."
Manufacturing Process	The device must be manufactured using the same processes as the predicate.	ZMR XL components are "manufactured... using the same processes."
Packaging	The device must be packaged using the same methods as the predicate.	ZMR XL components are "packaged... using the same processes."
Sterilization	The device must be sterilized using the same methods as the predicate.	ZMR XL components are "sterilized using the same processes."
Materials	The device must use the same materials as the predicate.	ZMR XL components are "materials" [used are the same]. (Implied by context of "same processes and materials").
Non-clinical Performance	The device must demonstrate equivalence to the predicate device through non-clinical testing.	"Non-clinical performance testing demonstrated that the device is equivalent to the predicate."

Study Details

Given the nature of this document (a 510(k) Summary of Safety and Effectiveness for a device modification), explicit details about a detailed study with specific performance metrics, sample sizes, and expert ground truth are not provided. The term "Performance Data" in this context refers to the non-clinical testing supporting substantial equivalence.

Here's what can be inferred or explicitly stated:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "Non-clinical performance testing," but does not detail the nature of this testing, the number of samples, or the data provenance. This typically refers to bench testing (e.g., mechanical, fatigue, wear) in a lab setting, not human subject data.
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/Not provided. For non-clinical performance testing of a hip prosthesis, "ground truth" as established by medical experts for diagnostic purposes (like radiologists) is not relevant. Performance is typically measured against engineering standards or predicate device specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are typically associated with clinical trials or diagnostic accuracy studies involving human interpretation. For non-clinical performance testing, test results are usually objective and compared directly to pre-defined specification limits or predicate device results.
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:
- No. An MRMC study is not relevant here. This is a hip prosthesis, not a diagnostic imaging device involving human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (hip prosthesis), not an algorithm or software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the medical expert sense. For non-clinical performance testing, the "ground truth" would be established engineering specifications, mechanical test standards (e.g., ISO or ASTM for implants), or direct comparison to the physical properties/performance of the predicate device. The document does not specify these details, only that "Non-clinical performance testing demonstrated that the device is equivalent to the predicate."
The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning model, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The "Z" is black, and the word "zimmer" is also black.

JUN 2 4 2003

Special 510(k): Device Modification

ZMR® Hip System-XL
Summary of Safety and Effectiveness

Submitter:

Contact Person:

Date:.

Trade Name:

Common Name:

Classification Name

and Reference:

Predicate Devices:

Device Description:

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

Karen Cain Manager, Regulatory Affairs Telephone: (574) 372-4219 Fax: (574) 372-4605

May 16, 2003

ZMR® Hip System-XL

Total hip prosthesis

Hip joint metal/polymer semiconstained uncemented prosthesis, no 21 CFR reference

Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis, 21 CFR 888.3358

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

K031572
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Intended Use:

The ZMR* Hip Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

Comparison to Predicate Device:

The modifications to the ZMR® Hip System change neither the intended use nor the fundamental scientific technology of the device. The ZMR XL components are manufactured, packaged and sterilized using the same processes and materials.

Performance Data:

Non-clinical performance testing demonstrated that the device is equivalent to the predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

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

FEB - 3 2012

Re: K031572 Trade/Device Name: ZMR™ Hip System-XL 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, LWJ Dated: May 16, 2003 Received: June 3, 2003

Dear Mr. Williman:

This letter corrects our substantially equivalent letter of June 24, 2003.

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 (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.

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Page 2 - Mr. Daniel Williman

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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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Indications for Use

510(k) Number (if known): K031572

Device Name:

ZMR® Hip System – XL

Indications for Use:

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)

(Division Sign-Off) Division o Surgical, Orthopedic, and Restorative Devices

510(k) Number K031572

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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.