(157 days)
No
The device description focuses on the material, design, and fixation method of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an acetabular cup, which is an implant used in total hip replacement surgery to treat conditions like advanced joint destruction, femoral head fractures, or failed previous surgeries. Its purpose is to restore joint function and alleviate pain, making it a therapeutic device.
No
The device described is an acetabular cup, which is a component of an artificial hip joint used for surgical replacement. Its function is to treat advanced joint destruction, fractures, or failed previous surgeries by replacing the damaged joint, not to diagnose a condition.
No
The device description clearly states it is a physical implant fabricated from UHMWPE, with specific dimensions and features for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Protek Low Profile Acetabular Cup is a physical implant fabricated from UHMWPE, designed to be surgically implanted into the acetabulum (part of the hip joint).
- Intended Use: The intended use is to replace or reconstruct a damaged hip joint due to various conditions like arthritis, fracture, or failed previous surgeries. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a medical device, specifically a prosthetic implant, used in orthopedic surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
888.3350
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (hip)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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) .
1
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. 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:
2
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.