(117 days)
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No
The document describes a mechanical implant (acetabular cup) and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical properties like push-out strength.
Yes.
The device is an orthopedic implant (acetabular cup and insert) used to treat painful, disabling joint disease of the hip, including conditions resulting from arthritis and avascular necrosis, which falls under the definition of a therapeutic device designed to alleviate a medical condition.
No
Explanation: The provided text describes an acetabular cup component used for hip replacement and revision surgeries. Its intended use and indications focus on treating painful joint disease and providing reconstructive solutions, not on diagnosing medical conditions.
No
The device description clearly states it consists of physical components: a metal shell and a polyethylene insert, which are implanted in the body. This 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 describes a surgical implant for replacing a hip joint. It is used in vivo (within the body) to treat painful and disabling joint disease.
- Device Description: The description details a physical implant consisting of a metal shell and a polyethylene insert, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially-available Osteonics metal acetabular shell component.
The indications for the use of the Osteonics® Modular Acetabular Cup, 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, theumatoid 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
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Device Description
The Osteonics® Modular Acetabular Cup components are single-use devices. Each Osteonics® Modular Acetabular Cup consists of two pieces: an Osteonics® PSL® MicroStructured® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The polyethylene insert is intended for cemented assembly to the metal shell.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Laboratory testing was undertaken to characterize the push-out strength of the Osteonics® ABC Cementable Polyethylene Inserts when assembled to their mating acetabular shells. The test results demonstrate that the shell/insert assembly method for the Osteonics® Modular Acetabular Cup components is comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Osteonics® Modular Acetabular Cup (MicroStructured® Version)
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Modular Acetabular Cup (MicroStructured® Version)
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Osteonics® Modular Acetabular Cup
Artificial Acetabular Component
Hip Joint Metal/Polymer/Metal Semi-Constrained, Porous Coated, Uncemented Prosthesis 21 CFR §888.3358
Predicate Device Identification
The Osteonics® Modular Acetabular Cup components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® Omnifit® PSL® MicroStructured® Shells: Osteonics Corporation. .
- Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation. .
- Osteonics® Omnifit® Cup Inserts: Osteonics Corporation. .
510(k) Summary
VAL.2@ub
JAN 27 1997
Osteonics Corporation
Allendale, NJ 07401-1677
Regulatory Affairs Specialist
59 Route 17
Terry Sheridan
October 1, 1996
1
Device Description
The Osteonics® Modular Acetabular Cup components are single-use devices. Each Osteonics® Modular Acetabular Cup consists of two pieces: an Osteonics® PSL® MicroStructured® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The polyethylene insert is intended for cemented assembly to the metal shell.
Intended Use:
The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially-available Osteonics metal acetabular shell component.
Indications:
The indications for the use of the Osteonics® Modular Acetabular Cup, 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, theumatoid 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® Modular Acetabular Cup System components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.
Materials:
Osteonics® PSL® MicroStructured® ABC Shells
The Osteonics® PSL® MicroStructured® ABC Shells, like the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells are manufactured from ASTM F-67 Commercially Pure Titanium, and feature a beaded, porous coating of ASTM F-67 CP Titanium beads.
2
Osteonics® ABC Cementable Polyethylene Inserts
The mating Osteonics® ABC Cementable Polyethylene Inserts, like the predicate Osteonics® Omnifit® Cup Inserts (Series II), are manufactured from UHMWPE.
Intended Use:
Osteonics® PSL® MicroStructured® ABC Shells
The subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells share the same indications for use, and both shells are intended for cemented or cementless fixation within the prepared acetabulum.
Osteonics® ABC Cementable Polyethylene Inserts
The subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts share the same indications for use. The Osteonics® ABC Cementable Polyethylene Inserts are intended for cemented assembly to their mating shells. This assembly method is predicated by the commercially available Osteonics® Omnifit® Cup Inserts (Series II), which have been determined substantially equivalent for cemented assembly to the commercially available Osteonics® Restoration GAP Acetabular Shells.
Design:
Osteonics® PSL® MicroStructured® ABC Shells
The subject Osteonics® PSL® MicroStructured® ABC Shells differ most notably from the commercially available Osteonics® Omnifit® PSL® MicroStructured® Shells with regard to their interior geometries. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert.
Both the subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Acetabular Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics® MicroStructured® coating.
Osteonics® ABC Cementable Polyethylene Inserts
The Osteonics® ABC Cementable Polyethylene Inserts have several features which make them relatively more amenable to the cemented assembly method than their predicate inserts. These features include:
- Machined-in grooves: These grooves allow interdigitation with the bone cement. .
- Roughened outer/back surface: The back/outer surface of the insert has been roughened . to provide a stronger insert/cement interface than would be characteristic of a smoother polyethylene surface.
Neither the machined in grooves, nor the roughened finish of the outer surface raise any new questions with regard to safety or effectiveness; both of these features are routinely employed in commercially available, one-piece, all-polyethylene acetabular cup designs.
3
Both the subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts (Series II) maintain a bearing area polyethylene thickness which is >6mm. Both the subject and the predicate inserts come in a wide range of inner diameter and outer diameter sizes. Both the subject and the predicate inserts come in versions with a 0°, 10°, or 20° hooded face.
Performance Data:
Laboratory testing was undertaken to characterize the push-out strength of the Osteonics® ABC Cementable Polyethylene Inserts when assembled to their mating acetabular shells. The test results demonstrate that the shell/insert assembly method for the Osteonics® Modular Acetabular Cup components is comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms.