femoral fracture
avascular necrosis of the femoral head
osteoarthritis
other abnormalities:
- where the major pathology affects the femoral head,
- where the acetabular cavity is normal and not deformed or weakened, and
- where acetabular replacement is not required or desirable.

Device Description

The J-FX Bipolar Head is composed of an Co-Cr-Mo alloy shell (ASTM F75) and a ultra-high-molecular weight polyethylene (UHMWPE) liner. The liner is a three piece design consisting of a bearing insert, inner retaining ring and an outer locking ring. The bearing insert and inner retaining ring provide the bearing surface for the femoral hip head while the locking ring holds the liner assembly in place in the shell.

The outer diameter of the metal shell varies in size from 38 through 58 mm in 1 mm increments for use with the 22.225 mm UHMWPE liner. For the 28 mm UHMWPE liner, the size range for the metal shell is 42 through 58 mm in 1 mm increments. A 60 mm metal shell is also available for use with both the 22.225 mm and 28 mm UHMWPE liner.

Five sizes of polyethylene liners are available for the 22.225 mm J-FX Bilpolar head and four sizes for the 28 mm J-FX Bipolar head. With this availability of liner sizes, the mating of the full range of outer shell sizes are met. The polyethylene thickness ranges from 4.1 to 12.1 mm for the 22.225 mm head and 3.7 to 9.2 mm for the 28 mm head.

AI/ML Overview

This document describes the J-FX Bipolar Head, a medical device for partial hip replacement. It is a 510(k) premarket notification. Therefore, the information provided below will largely focus on demonstrating substantial equivalence rather than detailed studies to prove novel acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For 510(k) submissions, the “acceptance criteria” and “device performance” are primarily demonstrated through comparison to a legally marketed predicate device. The key acceptance criterion is substantial equivalence in terms of indications for use, technological characteristics (materials, design), and performance (implied by the same materials and function).

Acceptance Criteria (Demonstrated by Equivalence to Predicate)	Reported Device Performance (as demonstrated by comparison to predicate)
Indications for Use: For partial hip replacement due to femoral fracture, avascular necrosis of the femoral head, osteoarthritis, and other abnormalities where major pathology affects the femoral head, the acetabular cavity is normal, and acetabular replacement is not required.	Identical to the predicate device (P.F.C.® Bipolar Hip System). Both devices are indicated for the same patient conditions and surgical scenarios.
Material Composition: Outer shell made of cobalt-chrome alloy; inner liner made of UHMWPE.	Identical to the predicate device (P.F.C.® Bipolar Hip System). The J-FX Bipolar Head uses Co-Cr-Mo alloy (ASTM F75) for the shell and UHMWPE for the liner.
Functionality: Metal/Polymer Femoral Head Endoprothesis (Bipolar Cup)	Identical to the predicate device. Both devices function as bipolar hip systems to articulate with the existing acetabulum.
Mechanical Design Principles: Bipolar Head design with an outer shell and an inner liner, accommodating different femoral head sizes.	Similar mechanical design with variations in specific sizes and a three-piece liner design, but based on the same established bipolar head principles as the predicate. The overall design achieves the same functional objective.

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

This is a 510(k) premarket notification for a Class II device. There is no explicit "test set" in the traditional sense of a clinical trial for this submission. Substantial equivalence is primarily established through:

Comparison of device specifications to the predicate device.
Bench testing to ensure material properties and mechanical performance meet established standards for similar devices. While not explicitly detailed in the provided text, such testing would have been part of the full submission, but it's not a "test set" with patient data.

Therefore, information on "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) related to patient data is not applicable in this summary as no such clinical study data is presented for direct evaluation of the J-FX Bipolar Head's performance in a patient population. The focus is on design and material equivalence to a device already proven safe and effective.

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

Not Applicable. As no clinical "test set" with patient data requiring ground truth establishment is described in this 510(k) summary, this information is not relevant. The "ground truth" for demonstrating substantial equivalence is the existence and established performance of the predicate device, recognized by the regulatory body.

4. Adjudication Method for the Test Set

Not Applicable. See point 2 and 3. No clinical test set requiring adjudication is detailed.

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 device is a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic system. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

Not Applicable. This is a mechanical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device (P.F.C.® Bipolar Hip System), which was cleared under premarket notifications K945793 and K931655. The J-FX Bipolar Head establishes its own "truth" of safety and effectiveness by demonstrating direct equivalence in materials, indications, and function to this already approved device.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device. The concept of a "training set" as understood in machine learning or AI is not relevant here. The design and manufacturing process would involve engineering principles and quality control, not a "training set" of data.

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

Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this device, there is no ground truth to establish for it. The "ground truth" for the device's design and manufacturing is adherence to material standards (e.g., ASTM F75 for Co-Cr-Mo alloy) and general Good Manufacturing Practices (GMP).

Summary

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K980801

Summary of Safety and Effectiveness Data for the J-FX Bipolar Head

MAY 2 9 1998

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person___________

Mary E. Gray Associate Regulatory Affairs Specialist Phone: (508) 828-3545 (508) 828-3212 Fax:

Name of Device________________________________________________________________________________________________________________________________________________________________

Proprietary Name:	J-FXTM Bipolar Head
Common Name:	Metal/Polymer Femoral Head Endoprothesis (Bipolar Cup)
Classification Name:	Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis.
Regulatory Class:	Class II by 21 CFR 888.3390
Product Code:	KWY
Owner/Operator No.:	9001269

Device Classification

This device has been placed in Class II for Hip joint femoral (hemi-hip) metal /polymer cemented < uncemented prosthesis per 21 CFR § 888.3390.

Statement of Substantial Equivalence

The J-FX Bipolar Head is substantially equivalent to the P.F.C.® Bipolar Hip System cleared for marketing under premarket notifications K945793 (April 10, 1995)/ K931655 (June 9, 1994). The devices are identical in material, with the outer shell composed of cobalt-chrome alloy and the inner liner composed of UHMWPE. Both devices are identical in function (indicated use).

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Indications for Use

The J-FX Bipolar Head is indicated for use in partial hip replacement procedures for patients suffering severe pain and disability due to:

femoral fracture
· avascular necrosis of the femoral head
· osteoarthritis
· other abnormalities:
- where the major pathology affects the femoral head,
- where the acetabular cavity is normal and not deformed or weakened, and
- where acetabular replacement is not required or desirable.

Physical Description

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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

Ms. Mary E. Gray Associate Requlatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re : K980801 Trade Name: J-FX™ Bipolar Head Regulatory Class: II Product Code: KWY Dated: February 25, 1998 Received: March 2, 1998

Dear Ms. Gray:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with .... . the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary E. Gray

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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SECTION II

Indications for Use

The J-FX Bipolar Head is indicated for use in partial hip replacement procedures for patients suffering severe pain and disability due to:

femoral fracture
· avascular necrosis of the femoral head
· osteoarthritis
other abnormalities:
- where the major pathology affects the femoral head,
- where the acetabular cavity is normal and not deformed or weakened, and
- where acetabular replacement is not required or desirable.

Prescription Use
(Per 21 CFR 801.109)

Acilla

(Division Sign-Off) ା : Division . . . 510(k) Number_1981) 80

J-FX Bipolar Head Premarket Notification February 25, 1998

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.