Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

Device Description

The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with commercially pure titanium alloy plasma spray.

The modular neck options allow for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of patient anatomies.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System." This is a medical device submission for a hip prosthesis, and as such, the acceptance criteria and study data provided are related to the physical and mechanical performance of the device, not diagnostic or AI performance.

Therefore, many of the typical questions for AI/diagnostic devices regarding sample size, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of submission.

Here's the breakdown of the information that is applicable and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance Requirements for Hip Prosthesis (Implied from substantial equivalence to predicate device)	Met performance requirements
Safety and Effectiveness (Implied from substantial equivalence to predicate device)	As safe and effective as its predicate

Explanation: The document states that "Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate." The specific numerical or qualitative acceptance criteria for "performance requirements" are not detailed in this summary document. These would typically be established through recognized standards (e.g., ISO for implant materials and mechanical testing) and internal company specifications for the similar predicate device.

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

Sample Size: Not specified. For non-clinical testing of a hip prosthesis, "samples" would refer to the physical devices or components subjected to laboratory tests (e.g., fatigue testing, wear testing).
Data Provenance: Not specified, but inherently "non-clinical" (i.e., laboratory testing). The country of origin for the data is Zimmer, Inc. (Warsaw, IN, USA). The studies are prospective in the sense that they are conducted specifically for this submission, but they are not clinical studies on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. For mechanical testing of medical devices like a hip prosthesis, "ground truth" is established by physical measurements, engineering principles, and adherence to recognized standards, rather than expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review contexts, typically in diagnostic studies. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is for evaluating the impact of a diagnostic tool (often AI) on human reader performance, which is not relevant for a hip prosthesis itself. The comparison here is between the new device and its predicate device based on manufacturing, materials, and intended use, and non-clinical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This question pertains to AI algorithms. The Zimmer M/L Taper Hip Prosthesis with Kinectiv™ Technology System is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

Engineering and Materials Standards / Predicate Device Performance: The "ground truth" for non-clinical testing of this device would be established by conforming to relevant industry standards (e.g., ISO standards for orthopedic implants), internal Zimmer specifications, and demonstrating equivalence to the performance of the legally marketed predicate device (Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology).

8. The Sample Size for the Training Set

Not applicable. This question refers to machine learning models. This document describes a physical medical device.

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

Not applicable. This question refers to machine learning models.

Summary

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Summary of Safety and Effectiveness

30 Jul 07

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dalene T. Binkley, RACSenior Associate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605
Date:	July 3, 2007
Trade Name:	Zimmer® M/L Taper Hip Prosthesis with Kinectiv™Technology System
Common Name:	Total Hip Prosthesis
Classification Nameand Reference:	1. KWA - Hip joint metal/metal semi-constrainedwith uncemented acetabular shell, 21 CFR § 888.33302. JDL - Hip joint metal/metal semi-constrainedwith cemented acetabular shell, 21 CFR § 888. 33203. LPH - Prosthesis, hip, semi-constrainedmetal/polymer porous uncemented, 21 CFR § 888.33584. LWJ - Prosthesis, hip, semi-constrainedmetal/polymer uncemented, 21 CFR § 888. 33605. MEH - Prosthesis, hip, semi-constraineduncemented metal polymer, non-porous, calciumphosphate, 21 CFR § 888. 3353
Predicate Device:	Zimmer® M/L Taper Hip Prosthesis with ModularNeck Technology, manufactured by Zimmer, Inc.,K063251, cleared January 24, 2007.

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Device Description:	The Zimmer M/L Taper Hip Prosthesis withKinectiv Technology System is a modular, wedge-shaped stem that is coated with commercially puretitanium alloy plasma spray.
	The modular neck options allow for soft tissuebalancing and easier restoration of the hip jointcenter of rotation. The modularity feature willallow surgeons to independently equalize leg lengthand optimize offset while, at the same time,maximizing joint stability for a variety of patientanatomies.
Intended Use:	Total hip replacement for the following: severe hippain and disability due to rheumatoid arthritis,osteoarthritis, traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of thefemoral head, nonunion of previous fractures of thefemur; congenital hip dysplasia, protrusio acetabuli,slipped capital femoral epiphysis; disability due toprevious fusion; previously failed endoprostheses,and/or total hip components in the affectedextremity and acute femoral neck fractures.
	Hemi-hip replacement for the following: fracturedislocation of the hip; elderly, debilitated patientswhen a total hip replacement is contraindicated;irreducible fractures in which adequate fixationcannot be obtained; certain high subcapital fracturesand comminuted femoral neck fractures in the aged;nonunion of femoral neck fractures; secondaryavascular necrosis of the femoral head; pathologicalfractures of the femoral neck; and osteoarthritis inwhich the femoral head is primarily affected.
	This femoral stem is for cementless use only.
Comparison to Predicate Device:	The Zimmer M/L Taper Hip Prosthesis with KinetivTechnology System is packaged, manufactured, andsterilized using the same materials and processes asits predicate. The subject device also has the sameintended use and fixation methods as the predicate.

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Ms. Dalene T. Binkley Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

K071856 Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Kinectiv® Technology System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LPH, LWJ, MEH Dated: July 3. 2007 Received: July 5, 2007

JUL 3 0 2007

Dear Ms. Binkley:

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 such 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); good manufacturing practice requirements as set

Image /page/3/Picture/9 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus-like symbol with three intertwined strands, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Re:

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Page 2 - Ms. Dalene T. Binkley

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara BruchuP

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t:JSG:afb:7/30/07 OC Numbers: Division of Enforcement A 240-276-0115 Dental, ENT and Ophthalmic Devices Branch 240-276-0115 OB/GYN, Gastro. & Urology Devices Branch 240-276-0115 General Hospital Devices Branch 240-276-0115 General Surgery Devices Branch 240-276-0115 Division of Enforcement B 240-276-0120 Cardiovascular & Neurological Devices Branch 240-276-0120 Orthopedic, Physical Medicine & Anesthesiology Devices and Radiological 240-276-0120 Devices

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071856

Indications for Use

510(k) Number (if known):

Device Name:

Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System

Indications for Use:

This femoral stem is for cementless use only.

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)

Barbara Medium for MAM

Division of Ge Restorati and Neurological Devices

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510(k) Number K071856

021

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.