(143 days)
Osteonics® All Polyethylene Acetabular Cups, DePuy Ogee® Acetabular Cups
Not Found
No
The device description and intended use focus on the physical characteristics and materials of a polyethylene acetabular cup for hip replacement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an acetabular component intended to treat painful and disabling hip joint diseases, which aligns with the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
Explanation: The device is an acetabular cup, which is an orthopedic implant for hip replacement surgery. Its intended use is to replace a diseased hip joint, not to diagnose a condition.
No
The device description clearly outlines physical components made of UHMWPE and cobalt chromium alloy, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cemented fixation within the prepared acetabulum" during hip replacement surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of polyethylene and cobalt chromium alloy, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Osteonics® Flanged Polyethylene Acetabular Cups are single-use devices which are intended for cemented fixation within the prepared acetabulum. The Osteonics® Flanged Polyethylene Acetabular Cups are compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Product codes
87 JDI
Device Description
The key features of the Osteonics® Flanged Polyethylene Acetabular Cups are:
- Size range: The cups are available in outer diameter (O.D.) sizes ranging from 40 64mm, . and inner diameter (I.D.) sizes of 22, 26, and 28mm.
- Materials: The body of each cup is made from ultra-high molecular weight polyethylene . (UHMWPE). Each cup features a cobalt chromium alloy x-ray marker wire.
- . Flanged design: The peripheral flange pressurizes the bone cement which may, in turn, improve the cement/bone interdigitation. The flange can be trimmed intraoperatively for a customized fit.
- Cement spacers: The outer/back face of the cup features cement spacers that are formed during . production by machined cuts made upon the surface of the spacers facilitate attainment of a uniform cement mantle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip / Acetabulum
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)
Comparative tests have been performed to evaluate the push-out strength, the torsional strength and the cement pressurization attainable with the subject devices. These tests have proven, with respect to these characteristics, that the subject devices are substantially equivalent to the cited predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Osteonics® All Polyethylene Acetabular Cups, DePuy Ogee® Acetabular Cups
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
FEB - 3 1997
Osteonics® Flanged Polyethylene Acetabular Cups & F
510(k) Summary
K963671 510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Flanged Polyethylene Acetabular Cups
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Terry Sheridan
Regulatory Affairs Specialist |
| Date of Summary Preparation: | September 12, 1996 |
| Device Identification | |
| Proprietary Name: | Osteonics® Flanged Polyethylene
Acetabular Cups |
| Common Name: | Artificial Acetabular Component |
| Classification Name and Reference: | Hip joint metal/polymer semi-
constrained cemented prosthesis
21 CFR §888.3350 |
| Device Panel/Product Code: | 87 JDI: Prosthesis, Hip, Semi-
constrained, Metal/polymer,
Cemented |
Predicate Device Identification
The Osteonics® Flanged Polyethylene Acetabular Cups are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® All Polyethylene Acetabular Cups ●
- DePuy Ogee® Acetabular Cups
1
Device Description
The key features of the Osteonics® Flanged Polyethylene Acetabular Cups are:
- Size range: The cups are available in outer diameter (O.D.) sizes ranging from 40 64mm, . and inner diameter (I.D.) sizes of 22, 26, and 28mm.
- Materials: The body of each cup is made from ultra-high molecular weight polyethylene . (UHMWPE). Each cup features a cobalt chromium alloy x-ray marker wire.
- . Flanged design: The peripheral flange pressurizes the bone cement which may, in turn, improve the cement/bone interdigitation. The flange can be trimmed intraoperatively for a customized fit.
- Cement spacers: The outer/back face of the cup features cement spacers that are formed during . production by machined cuts made upon the surface of the spacers facilitate attainment of a uniform cement mantle.
Intended Use:
The Osteonics® Flanged Polyethylene Acetabular Cups are single-use devices which are intended for cemented fixation within the prepared acetabulum. The Osteonics® Flanged Polyethylene Acetabular Cups are compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
The indications for the use of this acetabular component, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Statement of Technological Comparison:
The substantial equivalence of the Osteonics® Flanged Polyethylene Acetabular Cups to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.
Materials:
Both the subject and the predicate devices are manufactured from ultra-high molecular weight polyethylene, and feature x-ray marker wires.
2
Intended Use:
The subject devices and both of the predicate devices are intended for cemented use only. The subject devices and the predicate Osteonics devices identified above feature the same indications for use.
Design:
A comparison of the subject device against the predicate devices identified above demonstrates that the devices are substantially equivalent in terms of design features. All of these devices are, essentially, all-polyethylene cups. Each device features a rim or flange for increased cement pressurization. The flanges featured on the subject device and on the predicate Ogee Cup have been designed to allow the surgeon to trim them, as required, to intraoperatively address the specific patient's anatomy. Both the subject device and the predicate Osteonics® All Polyethylene Acetabular Cup feature cement spacers to facilitate the attainment of a uniform cement mantle. Both the subject device and the predicate devices come in a range of outer diameter and inner diameter size combinations to accommodate a wide range of patient anatomies.
Performance Data:
Comparative tests have been performed to evaluate the push-out strength, the torsional strength and the cement pressurization attainable with the subject devices. These tests have proven, with respect to these characteristics, that the subject devices are substantially equivalent to the cited predicate devices.