(78 days)
Osteonics® Secur-Fit™-HA PSL® Shells, Osteonics® Restoration GAP Acetabular Cups, Osteonics® Omnifit® Cup Inserts
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No
The summary describes a mechanical orthopedic implant (acetabular cup) and its components. There is 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 intended to treat painful, disabling joint disease of the hip and revise previous unsuccessful procedures.
No
The device is described as an implantable component for hip replacement surgery, not a tool used to diagnose medical conditions.
No
The device description clearly states it consists of physical components (shell and insert) intended for surgical implantation, indicating it is a hardware medical device.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant for hip replacement. It is a physical device intended to be surgically placed within the body.
- Intended Use/Indications: The intended use and indications clearly describe the treatment of painful hip joint conditions through surgical implantation, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory testing of patient specimens, or diagnostic purposes.
This device falls under the category of a medical device, specifically a surgical implant.
N/A
Intended Use / Indications for Use
The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. 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 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, 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
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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® Secur-Fit™-HA PSL® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was undertaken to characterize the push-out strength of the Osteonics® 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 (Sensitivity, Specificity, PPV, NPV, etc.)
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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® Secur-Fit™-HA PSL® Shells, Osteonics® Restoration GAP Acetabular Cups, Osteonics® Omnifit® Cup Inserts
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Modular Acetabular Cup (HA-Coated Version)
Submission Information
DEC 1 9 1996
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
October 1, 1996
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
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Osteonics® Modular Acetabular Cup
Artificial Acetabular Component
Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Non-porous Uncemented Prosthesis 21 CFR §888.3353
Predicate Device Identification
The Osteonics® Modular Acetabular Cup components are substantially equivalent to the following compeitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® Secur-Fit™-HA PSL® Shells: Osteonics Corporation. ●
- . Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation.
- Osteonics® Omnifit® Cup Inserts: Osteonics Corporation. .
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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® Secur-Fit™-HA PSL® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert.
Intended Use:
The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. 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 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, 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® Modular Cup components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.
Materials:
Osteonics® Secur-Fit™ HA PSL® ABC Shells
The Osteonics® Secur-Fit™-HA PSL® ABC Shells, like the predicate Osteonics® Secur-Fit™-HA PSL® Shells, are manufactured from CP Titanium, and feature an outer coating of arc-deposited CP Titanium and a plasma-sprayed coating of hydroxylapatite.
Osteonics® Cementable Polyethylene Inserts
The mating Osteonics® Cementable Polyethylene Inserts, like the predicate Osteonics® Omnifit® Cup Inserts (Series II) are manufactured from UHMWPE.
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Intended Use:
Osteonics® Secur-Fit ™-HA PSL® ABC Shells
The subject Osteonics® Secur-Fit™-HA PSL® ABC Shells and the predicate Osteonics® Secur-Fit™-HA PSL® ABC Shells share the same indications for use, and both shells are intended for cementless fixation within the prepared acetabulum.
Osteonics® Cementable Polyethylene Inserts
The 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® Secur-Fit™-HA PSL® ABC Shells
The subject Osteonics® Secur-Fit™-HA PSL® ABC Shell differs most notable from the commercially available Osteonics® Secur-Fit™-HA PSL® Shell with regard to its interior geometry. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert.
Both the subject Osteonics® Secur-Fit™-HA PSL® ABC Shells and the predicate Osteonics® Secur-Fit™ HA PSL® Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics' AD-HA 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.
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
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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® 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.