(58 days)
Osteonics" Secur-Fit™-HA PSL X'tra Acetabular Component System, Osteonics Secur-Fit™ AD Acetabular Component System
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No
The description focuses on the mechanical design, materials, and surgical application of an acetabular component, with no mention of AI or ML capabilities.
Yes.
The device is used to treat painful, disabling joint disease of the hip and to revise unsuccessful femoral head replacements, fitting the definition of a therapeutic device.
No
Explanation: The device is an acetabular component used in hip replacement surgery, which is a therapeutic intervention, not a diagnostic tool. Its purpose is to treat painful joint disease, not to diagnose it.
No
The device description clearly details physical components (shells, inserts) made of metal and polyethylene, intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided text, 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 description clearly states that the Osteonics® Normalized AD Acetabular Components are implants intended for surgical fixation within the prepared acetabulum (part of the hip joint).
- Intended Use/Indications: The intended use and indications describe the surgical implantation of the device to treat painful hip joint diseases and for revision procedures. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a medical device, specifically an orthopedic implant, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Osteonics® Normalized AD Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD Acetabular Components are compatible with any appropriately selected Osteonics hip stem/femoral head combination.
The indications for the use of the Osteonics® Normalized AD Acetabular Components, 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
Not Found
Device Description
Each Osteonics® Normalized AD Acetabular Component consists of two pieces: an Osteonics® Normalized AD Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum.
The Osteonics" Normalized AD Acetabular Shells are characterized by the following features:
- A basic spherical and tangent radii design.
- An interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- Peripheral screw holes. ●
- A dome hole which is compatible with the optional, currently marketed Osteonics" Acetabular . Dome Hole Plugs.
- Circumferential normalizations.
- A wide range of sizes from 50mm to 80mm.
- One of two screw hole configurations:
- 6 peripheral screw holes and no dome screw holes,
- 6 peripheral screw holes, and 5-7 dome screw holes.
- Osteonics' AD (arc deposited) coating.
The Osteonics® Omnifit® Scalloped Cup Inserts are available in 0°, 10°, and 20° configurations. These inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim. The scalloped rim allows for clearance between bone screws (which may be placed in the peripheral screw holes of the shell) and the insert's rim.
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)
A complete battery of tests, in accordance with the following FDA guidelines, was conducted to qualify and characterize the AD coating of the subject devices: FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994."
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" Secur-Fit™-HA PSL X'tra Acetabular Component System, Osteonics Secur-Fit™ AD Acetabular Component System
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
913015943076 P.02
APR 2 4 1997
Osteonics® Normalized AD Acctabular Component System
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Normalized AD Acetabular Component System
то
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date of Summary Preparation: | April 18, 1997 |
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Osteonics® Normalized AD Acetabular Component System
Artificial Acetabular Component
Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR §888.3350
Predicate Device Identification
The Osteonics Normalized AD Acetabular Components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics" Secur-Fit™-HA PSL X'tra Acetabular Component System: . Osteonics Corporation.
- . Osteonics Secur-Fit™ AD Acetabular Component System: Osteonics Corporation
S 10(k) Sunmary
1
Device Description
Each Osteonics® Normalized AD Acetabular Component consists of two pieces: an Osteonics® Normalized AD Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum.
The Osteonics" Normalized AD Acetabular Shells are characterized by the following features:
- · A basic spherical and tangent radii design.
- An interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- Peripheral screw holes. ●
- A dome hole which is compatible with the optional, currently marketed Osteonics" Acetabular . Dome Hole Plugs.
- Circumferential normalizations.
- . A wide range of sizes from 50mm to 80mm.
- One of two screw hole configurations:
- 6 peripheral screw holes and no dome screw holes, ।
- 6 peripheral screw holes, and 5-7 dome screw holes. ।
- . Osteonics' AD (arc deposited) coating.
The Osteonics® Omnifit® Scalloped Cup Inserts are available in 0°, 10°, and 20° configurations. These inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim. The scalloped rim allows for clearance between bone screws (which may be placed in the peripheral screw holes of the shell) and the insert's rim.
Intended Use:
The Osteonics® Normalized AD Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD Acetabular Components are compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
The indications for the use of the Osteonics® Normalized AD Acetabular Components, 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.
2
Statement of Technological Comparison:
The substantial equivalence of the Osteonics® Normalized AD Acetabular Components to the predicate devices identified above-in terms of intended use, materials, and design features-is based on the following.
Intended Uses:
The Osteonics® Normalized AD Acetabular Components, like the predicate Osteonics® Secur-Fit AD acetabular components cited above, are intended for cementless fixation. The subject devices and the predicate devices share indications for use.
Materials:
The Osteonics" Normalized AD Acetabular Shells and the predicate Osteonics® Secur-Fit AD Acetabular Shells cited above are manufactured from the same materials. Both devices have a shell substrate machined from F-67 CP Titanium. Both devices feature Osteonics' AD coating (arc-deposited CP Ti).
The Osteonics® Omnifit® Scalloped Cup Inserts and the predicate Osteonics® Omnifit® Cup Inserts are both manufactured from ultra-high molecular weight polyethylene, and feature a locking wire made from cobalt chromium alloy.
Design:
The design of the Osteonics Normalized AD Acetabular Shells is consistent with that of the predicate Osteonics Secur-Fit™-HA PSL® X'tra Acetabular Components and differs only in the following:
- The subject acetabular shells feature 6 peripheral screw holes; whereas the predicate devices feature from 6 - 8 peripheral screw holes.
- The peripheral screw holes of the subject shell are completely enclosed within the shell rim; whereas the peripheral screw holes of the predicate shell "break out" from the shell rim.
- The outer geometry of the subject devices features a hemispherical, tangent radii design, whereas the outer geometry of the predicate devices features Osteonics' Dual Radius : geometry.
- There is no HA coating covering the arc deposition coating. -
The Osteonics® Omnifit® Scalloped Cup Inserts differ from the predicate Osteonics® Omnifie Cup Inserts in that they feature a scalloped rim.
None of these design differences raises any new questions of safety or effectiveness.
3
Summary
Based on the similarities presented above, the supporting testing summary reproduced in Appendix C, the pre-clinical data incorporated by reference to prior submissions, and the fact that the Osteonics Normalized AD Acetabular Components employ standard sterilization and packaging methods, the substantial equivalence of the Osteonics Normalized AD Acetabular Components to other legally marketed, class II, acetabular components is demonstrated.
Performance Data:
A complete battery of tests, in accordance with the following FDA guidelines, was conducted to qualify and characterize the AD coating of the subject devices: FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994."