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

Device Description

The CPT (Collarless Polished Taper) Hip System is designed for cement fixation into the intramedullary canal for pathological or degenerative conditions involving the femur that merit total hip arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification for the CPT Hip System, a medical device for cemented hip arthroplasty. The submission claims substantial equivalence to previously marketed predicate devices.

Here's the breakdown of the requested information based on the provided text:

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

The document does not explicitly present "acceptance criteria" in the typical sense of quantitative benchmarks, but rather demonstrates substantial equivalence to predicate devices through various non-clinical tests. The "reported device performance" refers to the results of these tests, which support the claim of substantial equivalence.

Acceptance Criteria Category (Implied)	Specific Tests Performed and Reported Performance (Supporting Substantial Equivalence)
Intended Use	Identical to predicates
Indications for Use	Substantially equivalent to predicates. The listed indications (severe hip pain due to various arthritis types, avascular necrosis, nonunion of fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability from previous fusion, failed endoprostheses, acute femoral neck fractures) align with the predicates.
Materials	Identical to predicates
Design Features	Substantially equivalent to predicates
Sterilization	Identical to predicates
Mechanical Performance	Non-Clinical Tests: - Proximal fatigue testing per internal requirements - Distal fatigue testing per internal requirements - Finite Element Analysis for worst-case proximal fatigue strength per ISO 7206-6 - Finite Element Analysis for worst-case in distal fatigue per ISO 7206-4 - Range of Motion analysis per ISO 21535 and internal requirements - Fretting/Corrosion testing per ASTM F1875 - Anatomic fatigue testing and accelerated corrosion fatigue testing per internal requirements - Load to failure, insertion force, and stem subsidence testing for distal stem centralizers. (The implicit performance is that these tests demonstrated safety and functionality comparable to the predicate devices).
Clinical Performance	No clinical test data provided; reliance on substantial equivalence to predicates as the basis for safety and effectiveness.

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

The document explicitly states: "Clinical test data is not provided for the subject device." Therefore, there is no clinical test set, sample size, or patient data provenance to report. The evaluation is based on non-clinical (bench) testing and comparison to predicate devices.

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. As no clinical test data was provided, there was no need for experts to establish ground truth for a clinical test set. The ground truth for the substantial equivalence claim relies on the established performance and safety profiles of the predicate devices and the non-clinical engineering tests conducted on the subject device.

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

Not applicable. Without a clinical test set requiring human interpretation of data, there is no adjudication method implemented or described.

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

Not applicable. This is a submission for a hip prosthesis, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a physical medical device (hip prosthesis), not a software algorithm.

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

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is established through:

Engineering specifications and regulatory standards: The non-clinical tests (e.g., fatigue testing, FEA, ROM analysis, fretting/corrosion) are evaluated against established internal requirements, ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535), and ASTM standards (ASTM F1875).
Performance of legally marketed predicate devices: The "ground truth" for the subject device's safety and effectiveness is largely benchmarked against the known performance and safety profiles of the already cleared predicate devices (K960658 COLLARLESS POLISHED TAPER HIP PROSTHESIS and K030265 CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00), to which it claims substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so 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 device.

Summary

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September 17, 2020

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Zimmer Inc Caleb Barylski Specialist, Regulatory Affairs 1800 W Center Street Warsaw, Indiana 46580

Re: K191735

Trade/Device Name: CPT Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI

Dear Caleb Barylski:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 20, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Vesa Vuniqi, OHT6: Office of Orthopedic Devices, 1-301-796-5773, vesa.vuniqi@fda.hhs.gov.

Sincerely,

Vesa Vuniqi -S

Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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March 20, 2020

Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer Inc Caleb Barylski Specialist, Regulatory Affairs 1800 W Center Street Warsaw, Indiana 46580

Re: K191735

Trade/Device Name: CPT Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI Dated: February 20, 2020 Received: February 21, 2020

Dear Caleb Barylski:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2020.03.20 09:44:18 -04'00'

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191735

Device Name CPT Hip System

	Indications for Use (Describe)
r	CASES PERSONAL CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSU

The CPT Hip System is indicated for cemented use in:

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the CPT Hip System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s,' issued on September 13, 2019.

Sponsor:	Zimmer, Inc.1800 W. Center StreetWarsaw, IN 46580Establishment Registration Number: 1822565
Contact Person:	Caleb BarylskiSpecialist, Regulatory AffairsTelephone: (574-371-0250)
Date:	19-Mar-2020
Subject Device:	Trade Name: CPT Hip SystemCommon Name: Hip Prosthesis
	Classification Name:• JDI - Prosthesis, Hip, Semi-Constrained,Metal/Polymer, Cemented (21 CFR 888.3350)
Predicate Device(s):	K960658 COLLARLESSPOLISHEDTAPER HIPPROSTHESIS Zimmer, Inc.
	K030265 CPT 12/14 HIPPROSTHESES,MODEL 00-8114-040/050-00 Zimmer, Inc.
Purpose and Device Description:	The CPT (Collarless Polished Taper) Hip System isdesigned for cement fixation into the intramedullary canalfor pathological or degenerative conditions involving thefemur that merit total hip arthroplasty.The current submission is a retrospective 510(k) fordevices that are currently marketed in the U.S. Through areview of the changes to the device system based on the

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current FDA Guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device" (October 25, 2017), Zimmer Inc. has decided to submit a 510(k) for the cumulative changes.

Intended Use and Indications for Use:

The CPT Hip System is indicated for cemented use in:

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

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical to predicates ●
Indications for Use: Substantially equivalent to ● predicates
Materials: Identical to predicates ●
Design Features: Substantially equivalent to ● predicates
. Sterilization: Identical to predicates

Summary of Performance Data (Nonclinical and/or Clinical):

Non-Clinical Tests:

Proximal fatigue testing per internal requirements O
Distal fatigue testing per internal requirements O
Finite Element Analysis for worst-case proximal O fatigue strength per ISO 7206-6
Finite Element Analysis for worst-case in distal O fatigue per ISO 7206-4
Range of Motion analysis per ISO 21535 and O internal requirements
Fretting/Corrosion testing per ASTM F1875 O
Anatomic fatigue testing and accelerated O corrosion fatigue testing per internal requirements

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o Load to failure, insertion force, and stem subsidence testing for distal stem centralizers
Clinical Tests: ●
- Clinical test data is not provided for the subject o device.

Substantial Equivalence Conclusion:

The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the legally marketed predicate devices.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.