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.

Device Description

The Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. Calcicoat® Ceramic Coating (hydroxyapatite tricalcium phosphate [HA/TCP]) has been added to the porous coating to aid bony ingrowth.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with detailed acceptance criteria and performance metrics against human readers or pathology.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets as would be found in AI/ML device submissions are not applicable here.

The crucial information provided relates to the non-clinical performance and comparison to a predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance
Device materials and processes: Same as predicate device.	The M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating is manufactured, packaged, and sterilized using the same materials and processes as the predicate devices.
Intended use and fixation methods: Same as predicate device.	The subject device also has the same intended use and fixation methods as the predicate devices.
Performance requirements: Meet performance requirements and be as safe and effective as the predicate device.	Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating met performance requirements and is as safe and effective as the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this type of submission. This submission relies on non-clinical testing and comparison to a predicate device, not a human reader performance study or a clinical test set with a specific sample size of cases in the way an AI/ML device would. The "test set" here refers to the physical samples of the device undergoing non-clinical tests. The document does not specify the number of hip prostheses tested. The provenance would be the manufacturing site (Warsaw, IN, USA).

3. 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. "Ground truth" in the context of this device does not pertain to expert review of images or data, but rather to the physical, chemical, and mechanical properties of the device as assessed through non-clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for clinical trials or expert consensus in data labeling, which is not part of this 510(k) submission.

5. 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. This is a medical device (hip prosthesis), not an AI/ML diagnostic or assistive tool. Therefore, MRMC comparative effectiveness studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through non-clinical testing (e.g., mechanical strength, wear resistance, biocompatibility, coating adhesion, etc.) according to recognized standards and engineering principles, demonstrating that it meets performance requirements and is equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a "training set" in the context of machine learning.

Summary

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K042337

K0425537
NOV - 4 2004Summary of Safety and Effectiveness
Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dalene Binkley, RACAssociate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605
Date:	August 27, 2004
Trade Name:	Zimmer® M/L Taper Hip Prosthesis with Calcicoat®Ceramic Coating
Common Name:	Total Hip Prosthesis
Classification Name:	Hip joint metal/polymer/metal semiconstrainedporous coated uncemented prosthesis
Reference and Product Code:	21 CFR § 888.3358, LPH
Predicate Device:	Zimmer® M/L Taper Hip Prosthesis, manufacturedby Zimmer, Inc., K032726, cleared October 22,2003.
Device Description:	The Zimmer® M/L Taper Hip Prosthesis withCalcicoat® Ceramic Coating is a modular, titaniumalloy femoral stem designed to replace the proximalhuman femur in total hip arthroplasty. It is flat,collarless, and features a proximal-to-distal taper inthe mediolateral (M/L) plane. The wedge-shapedprosthesis is designed for cementless use and iscircumferentially porous-coated with titanium alloyplasma spray over the proximal body region.Calcicoat® Ceramic Coating (hydroxyapatitetricalcium phosphate [HA/TCP]) has been added tothe porous coating to aid bony ingrowth.
Intended Use:	Total hip replacement for the following: severe hippain and disability due to rheumatoid arthritis,osteoarthritis, traumatic arthritis, polyarthritis,

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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.

The M/L Taper Hip Prosthesis with Calcicoat * Ceramic Coating is manufactured, packaged, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices

Performance Data (Nonclinical and/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating met performance requirements and is as safe and effective as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2004

Ms. Darlene Binkley, RAC Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K042337

Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Calicoat® Ceramic Coating 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 Dated: October 13, 2004 Received: October 15, 2004

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 practicc 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.

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Page 2 - Ms. Darlene Binkley, RAC

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating

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 (ONE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K042337 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.