Advanced Joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head.
Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Device Description

The Protek Low Profile Acetabular Cup (Catalog No. ) is fabricated from ultra molecular high weight polyethylene (UHMWPE) . . The Protek Low Low Low Profile Acetabular Cup is spherical in design and employs longitudinal cement channels and circumferential cement grooves along the outer surface of the cup. The longitudinal cement channels and vertical grooves provides greater cement interdigitation with PMMA bone cement. addition, the Protek Low Profile in Acetabular Cup employs radiographic marker wires along the periphery of the outer rim and on the superior outer portion of the acetabular cup. smaller sizes of the Protek The LOW Profile Acetabular Cup [Sizes 22mm (ODs' 36, 38, and 40mm), 28mm (OD 42mm), and 32mm (ODs' of 44 and 46mm)], with a minimum polyethylene thickness of 6mm are intended only for use with the Protek acetabular reinforcement devices which are utilized in patients with acetabular bone deficiencies. The Protek acetabular reinforcement devices have been determined substantially equivalent by the FDA via 510 (k) #K953578. The Protek Low Profile Acetabular Cup is available in inner diameters of 22, 28, and 32mm, with outer diameter sizes ranging from 36 to 64mm with -2mm increments. The Protek Low Profile Acetabular Cup, like the predicate acetabular components, is intended for cemented fixation within the prepared acetabulum.

AI/ML Overview

This document is a 510(k) Premarket Notification Summary for a medical device, specifically an acetabular cup for total hip replacement. The purpose of this summary is to demonstrate substantial equivalence to previously marketed devices, not to present a study proving the device meets specific acceptance criteria through clinical trials or performance metrics.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or statistical performance data.

The document focuses on comparing the "Protek Low Profile Acetabular Cup" to predicate devices (already legally marketed) based on:

Materials: Both the subject device and predicate devices are made from ultra high molecular weight polyethylene (UHMWPE).
Intended Use: Both the subject device and predicate devices are intended for cemented application in total hip replacement for similar indications (e.g., advanced joint destruction, fracture, failed previous surgeries).
Design Characteristics: Both are spherical in design and employ longitudinal cement channels.

The concept of "acceptance criteria" in this context refers to demonstrating substantial equivalence, which is assessed qualitatively against predicate devices, not through a quantitative performance study with predefined statistical targets. There are no reported device performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because this type of premarket notification does not typically involve such studies for demonstrating equivalency of a Class II device of this nature.

Summary

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JUN - 7 1996

510 (k) Premarket Notification Summary of Safety and Effectiveness for Protek Low Profile Acetabular Cup

COORS

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Protek Low Profile Acetabular Cup.

Submitter : Intermedics Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas, 7871'
Tel.: (512) 432-9900 78717 Fax: (512) 432-9291

Contact Person: Jacquelyn Hughes Manager, Requlatory Affairs

Date: December 29, 1995

Proprietary name Protek Low Profile Acetabular Cup

Prosthesis,

devices:

Metal/Polymer,

Common Name : Total hip replacement acetabular component

Classification name:

ﺘﺤ

Predicate Devices:

888.3350) . employed by The features Protek Low Profile Acetabular Cup are substantially equivalent to the features employed by the following predicate legally marketed

Cemented

Hip,

Semi-constrained,

(21CFR

1 Apollo All Poly Hooded Acetabular Component: Intermedics Orthopaedics Inc. (510(k) #K933203).
D Richards Cemented Acetabular Smith Component : and Nephew Richards (510(k) number unknown to IOI) .
1 Osteonics All Poly Acetabular Cup: Osteonics Corporation (510 (k) number unknown to IOI).
1 Ultima Polyethylene Acetabular Cup: Johnson Johnson Orthopaedics Grander Grand (1988) Grander (1992) Granders (1992) Granders (1992) Granders (1992) Granders (1992) Granders (1992) Granders (1992) Granders (1992) Granders (1992) (510 (k) number unknown to IOI) .

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Device Description:

smaller sizes of the Protek The LOW Profile Acetabular Cup [Sizes 22mm (ODs' 36, 38, and 40mm), 28mm (OD 42mm), and 32mm (ODs' of 44 and 46mm)], with a minimum polyethylene thickness of 6mm are intended only for use with the Protek acetabular reinforcement devices which are utilized in patients with acetabular bone deficiencies. The Protek acetabular reinforcement devices have been determined substantially equivalent by the FDA via 510 (k) #K953578.

The Protek Low Profile Acetabular Cup is available in inner diameters of 22, 28, and 32mm, with outer diameter sizes ranging from 36 to 64mm with -2mm increments.

The Protek Low Profile Acetabular Cup, like the predicate acetabular components, is intended for cemented fixation within the prepared acetabulum. The Indications for Use for the Protek Low Profile Acetabular Cup are as follows:

Advanced Joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head.
Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Intended Use:

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Summary of Technological Characteristics :

1000

The features of the Protek Low Profile Cup are substantially Acetabular aforementioned the equivalent to predicate Protek and/or competitive devices in terms of materials, intended use and design characteristics. comparison of the features of the Protek Low Profile Acetabular Cup in terms of intended use design and materials, characteristics to the aforementioned predicate devices is as follows:

Materials:

Substantial equivalence in terms of materials is based upon the fact that both the subject device and the legally marketed predicate devices are fabricated high molecular weight ultra from polyethylene (UHMWPE).

Intended Use:

The Protek Low Profile Acetabular Cup, like the predicate acetabular components, is intended for cemented application. subject device and the predicate The devices share the same indications for Therefore, in terms of intended use use. subject device is substantially the legally the marketed equivalent to predicate devices.

Design characteristics:

The Protek Low Profile Acetabular Cup, like the predicate acetabular components, spherical in design and employs longitudinal cement channels along the outer surface of the cup. Therefore, in of design characteristics the terms device is substantially subject to the legally marketed equivalent predicate devices.

A side by side tabular comparison of the features of the Protek Low Profile Acetabular Cup to those of the predicate devices follows.

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.