(78 days)
Not Found
No
The 510(k) summary describes a physical medical device (acetabular components for hip replacement) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The focus is on the material properties, design features, and mechanical performance of the implant.
Yes
The device is an acetabular component intended to treat painful, disabling joint disease of the hip, which aligns with the definition of a therapeutic device.
No
The device is an orthopedic implant (acetabular components) used for hip replacement surgery, not for diagnosing conditions.
No
The device description clearly details physical components (shells, inserts) made of metal and featuring coatings and screw holes, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
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 "cementless fixation within the prepared acetabulum" as part of a hip replacement procedure. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Indications for Use: The indications describe painful and disabling joint disease of the hip, requiring surgical intervention. This further reinforces its role as a surgical implant.
- Device Description: The description details the physical components of the device (metal shell, polyethylene insert) and their features, all related to its function as a hip implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
In summary, the Osteonics® Normalized AD-HA Acetabular Components are a surgical implant used in hip replacement surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD-HA Acetabular Components 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 (comma separated list FDA assigned to the subject device)
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis 21 CFR §888.3353
Device Description
Each The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. Osteonics® Normalized AD-HA Acetabular Component consists of two pieces: an Osteonics® Normalized AD-HA Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.
The Osteonics" Normalized AD-HA Acetabular Shells are characterized by the following features:
- A basic spherical and tangent radii design.
- The predicate 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.
- 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-HA coating.
The Osteonics® Omnifit® Scalloped Cup 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
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-HA coating of the subject devices: FDA's "Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants, November 11, 1992" and 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.
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
§ 888.3353 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.
0
Osteonics® Normalized AD-HA Acetabular Component System
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Normalized AD-HA Acetabular Component System
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: | January 31, 1997 |
| Device Identification | |
| Proprietary Name: | Osteonics® Normalized AD-HA
Acetabular Component System |
Artificial Acetabular Component
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis 21 CFR §888.3353
Predicate Device Identification
Common Name:
Classification Name and Reference:
The Osteonics® Normalized AD-HA 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.
510(k) Summary
1
Device Description
Each The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. Osteonics® Normalized AD-HA Acetabular Component consists of two pieces: an Osteonics® Normalized AD-HA Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.
The Osteonics" Normalized AD-HA Acetabular Shells are characterized by the following features:
- · A basic spherical and tangent radii design.
- . The predicate 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. .
- 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-HA coating.
The Osteonics® Omnifit® Scalloped Cup 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-HA Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD-HA 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-HA 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-HA 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-HA Acetabular Compopnents, like the predicate acetabular components cited above, are intended for cementless fixation. The subject devices and the predicate devices share the same indications for use.
Materials:
The Osteonics Normalized AD-HA Acetabular Shells and the predicate acetabular shells cited above are manufactured from the same materials. Both devices have a shell substrate machined from ASTM F-67 CP Titanium. Both devices feature Osteonics' AD-HA coating (arc-deposited CP Ti, beneath plasma-sprayed hydroxylapatite).
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 Osteonics Normalized AD-HA Acetabular Shells differ from the predicate Osteonics Secur-Fit™-HA PSL® X'tra Acetabular Components as follows:
- । 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.
The Osteonics® Omnifit® Scalloped Cup Inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim.
None of these design differences raises any new questions of safety or effectiveness.
Summarv
Based on the similarities presented above, the supporting testing reproduced in Appendix C, the pre-clinical data incorporated by reference to prior submissions, and the fact that the Osteonics
3
Normalized AD-HA Acetabular Components employ standard sterilization and packaging methods, the substantial equivalence of the Osteonics Normalized AD-HA 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-HA coating of the subject devices: FDA's "Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants, November 11, 1992" and FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994. "