FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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.

The Trident shells are intended for cementless fixation within the prepared acetabulum.

Tritanium Acetabular Shell System

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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.

The Tritanium Acetabular Shell System is intended for cementless use only.

Accolade II Femoral Stem, Secur-Fit Advanced Femoral Stem, Anato Femoral Stem
The indications for use for total hip arthroplasty with stems include:

noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:
When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II, Secur-Fit Advanced and Anato Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

Exeter® V40TM Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Hip System is intended for use in total hip replacement. It is intended for cemented use only.

The Exeter® Hip is indicated for:

noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
rheumatoid arthritis:
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Restoration Anatomic Shell
Indications for Use

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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.

When used with MDM Liners

Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks

When used with Constrained Liner:

The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.

Omnifit HFX Femoral Stems
Indications:
For use as a Bipolar Hip Replacement:

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty.
Femoral neck fractures.

For use as a Total Hip Replacement:

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.
Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.

Omnifit EON Cemented Femoral Stems
Indications
For use as a Bipolar Hip Replacement:

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

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.

Secur-Fit Max and Secur-Fit Max Plus Hip Stems
Secur-Fit Max and Secur-Fit Max Plus Hip stems are single use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.

Indications for use as a Total Hip Replacement include:

noninflammatory degenerative joint disease. including osteoarthritis and avascular necrosis:
rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade C Femoral Stems
The Accolade C Femoral Stems are single-use devices intended for cemented fixation.

Indications for use as a Total Hip Replacement include:

noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade HFx Femoral Stems

noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
rheumatoid arthritis:
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' trunnion.

Indications:

Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Revision procedures where other treatments or devices have failed.

Restoration Acetabular Wedge Augments
The indications for use of the Restoration Acetabular Wedge Augments:

General Indications for Total Hip Replacement Components:

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.

Indications Specific to the Acetabular Wedges:

As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface, and are affixed to the mating cup using bone cement

Trident AD Acetabular shells
The Trident AD Acetabular shells are single use devices. The shell is intended for cemented or cementless fixation within the prepared acetabulum. The Trident AD Acetabular Component System is compatible with any appropriately selected Howmedica 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.

Trident T Acetabular shells
The Trident Acetabular shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident polyethylene acetabular bearing insert. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.

General Indications for Total Hip Replacement Components:

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.

Restoration ADM System, Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert
The indications for use of the total hip arthroplasty prostheses include:

Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis:
Correction of functional deformity; .
Revision procedures where other treatments or devices have failed;
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks.

These devices are intended for cementless use only

Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the acetabular cup. The Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.

Indications

In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.
Trident X3, Trident Crossfire, Trident X2Vac and Trident X3/Crossfire Elevated Rim Acetabular Liners
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 bv deficiencies of the acetabulum.

Trident® Constrained Acetabular Insert
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

BIOLOX Delta Ceramic Heads (C-Taper, Universal Taper, V40 to Universal Taper Adapter Sleeve, and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

For Use as a Total Hip Replacement:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous cup arthroplasty or other procedures
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 in the acetabulum.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty

V40 BIOLOX Delta Ceramic Heads
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

For Use as a Total Hip Replacement:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous cup arthroplasty or other procedures
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions. .
Aseptic necrosis of the femoral head.
Osteo-. rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other considerations:

Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty

Alumina C-Taper Ceramic Heads
For Use as a Total Hip Replacement:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
Revision of previous cup arthroplasty or other procedures
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty .

Alumina V40 Ceramic Heads

Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
Rheumatoid arthritis
Correction of functional deformity
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by the deficiencies of the acetabulum;
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques;
Revision procedures where other treatments or devices have failed.

C-Taper CoCr Femoral Heads (LFIT and non-LFIT)
For use as a Bipolar Hip Replacement:

Femoral head/neck fractures or non-unions 1.
1. Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement 3. or distortion.

Other Considerations:

1. Pathological conditions or age considerations which indicate a more conservative approach to the acetabulum and the avoidance of the use of bone cement in the acetabulum.
1. Salvage of failed total hip arthroplasty.

Indications for use as part of a Total Hip Replacement include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 1. arthritis, post-traumatic arthritis or late stage avascular necrosis.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
1. Clinical management situations where arthrodesis or alternate reconstructive techniques are less likely to achieve satisfactory results.
  V40 CoCr Femoral Heads (LFIT and non-LFIT)
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis
Correction of functional deformity
Revision procedures where other treatments or devices have failed
Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Unitrax Endoprosthesis, Unitrax V40 Adapter Sleeve, Unitrax C-Taper Adapter Sleeve

The Howmedica Osteonics Unitrax Endoprosthesis, and the Unitrax V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and non-unions. The Unitrax C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or non-unions, aseptic necrosis of the femoral head/neck and osteo- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis.
Universal Distal Spacer
Howmedica Osteonics Corp.'s accessory products for cemented arthroplasty are optional devices intended to assist in the preparation, implantation and/or positioning of a femoral implant intended for cemented application.

Indications
For cement spacers, mid-shaft restrictors and Cement Plugs:

In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
Torx Screws, GAP Plate Screws and Osteolock Bone Screws
Howmedica Osteonics Torx Cancellous Bone Screws are intended for supplemental fixation of associated Howmedica Osteonics cementless Acetabular Shells or Howmedica Osteonics Tibial Tray components.
Howmedica Osteonics Osteolock Bone Screws are intended for supplemental fixation of associated cementless Trident Tritanium Multihole Acetabular shells, Restoration Acetabular Augments, and Restoration Anatomic Shell.
Howmedica Osteonics Restoration GAP Plate Screws are intended only for fixation of the dome and iliac plates of the associated Howmedica Osteonics Restoration GAP Acetabular Shells, Trident Tritanium Hemispherical Multihole Acetabular Shells, Restoration Acetabular Augments and Restoration Anatomic Shell.

V40 to C-Taper Adapter Sleeve For Use as a Total Hip Replacement

Painful disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis.
Revision of previous cup arthroplasty or other procedures.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty.

Device Description

All of the subject devices have been found substantially equivalent in previous premarket indications. The purpose of this submission is to modify the labeling to add MR compatibility to the labeling for the devices indicated above, and to remove a contraindication for selected devices. There have been no changes made to the devices requiring 510(k) clearance - only the labeling is being modified.

AI/ML Overview

The provided text is a 510(k) Summary for a labeling update of Stryker Orthopaedics Total Hip Systems, not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a labeling update to include MR compatibility and remove a contraindication. It mentions non-clinical testing for MR compatibility but does not provide specific acceptance criteria or performance numbers in the requested format.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Study Supporting Device Performance

Not directly available. This document is a 510(k) summary for a labeling update, not an original submission demonstrating device performance against specific clinical or non-clinical acceptance criteria with quantitative results. It describes non-clinical testing performed to update MR compatibility labeling, but it does not present acceptance criteria in a table format with corresponding device performance metrics.

What is present regarding testing:
Non-clinical laboratory testing was performed to characterize the MR compatibility of the devices. The tests were conducted according to specific ASTM standards:

ASTM F2052-06 and ASTM F2052-14 for Magnetically Induced Displacement Force.
ASTM F2213-06 (Reapproved 2011) for Magnetically Induced Torque.
ASTM F2119-07 (Reapproved 2013) for Image Artifact.
ASTM F2182-11a for Heating by RF Fields.

The document states that the labeling was modified to include the MR conditional symbol and provide parameters for safe scanning, and for certain devices, a contraindication was removed. This implies that the devices met the requirements of these ASTM standards for MR compatibility, allowing for the labeling update. However, no specific numerical "acceptance criteria" or "reported device performance" are provided in a table.

Detailed Breakdown of Requested Information:

A table of acceptance criteria and the reported device performance
- Not available in this document. The document describes the type of non-clinical tests performed (e.g., Magnetically Induced Displacement Force per ASTM F2052-06) for MR compatibility, but it does not provide a table with specific numerical acceptance criteria (e.g., "Displacement less than X") and the corresponding measured performance (e.g., "Measured displacement Y"). It only states that the labeling was updated to reflect MR compatibility based on these tests.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document mentions non-clinical laboratory testing but does not specify sample sizes for these tests (e.g., how many hip components were tested for MR compatibility). It is a regulatory submission, not a research paper detailing experimental methodology. Data provenance for non-clinical lab tests is not typically documented in this way in a 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not available. The testing described is non-clinical "MR compatibility" testing performed in a laboratory setting, not clinical evaluation requiring expert interpretation or ground truth establishment in a diagnostic context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. As the testing is non-clinical (laboratory-based MR compatibility), there is no adjudication process involving human interpretation of results in the way it would be for a clinical diagnostic study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission is for a labeling update for existing orthopedic implants and does not involve AI or any diagnostic imaging interpretation requiring an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a labeling update for existing orthopedic implants and does not involve an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not available. For the non-clinical MR compatibility testing, the "ground truth" would be the physical properties and responses of the hip system components under MR conditions, as measured by the ASTM standards, not a clinical "ground truth" like pathology or expert consensus. These are engineering measurements.
The sample size for the training set
- Not applicable. This submission relates to physical orthopedic implants and MR compatibility testing, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established
- Not applicable. This submission relates to physical orthopedic implants and MR compatibility testing, not a machine learning algorithm that requires a training set.

In summary, the provided document is a regulatory submission focusing on demonstrating substantial equivalence for a labeling change for established orthopedic implants, particularly concerning MR compatibility. It outlines the types of non-clinical tests performed but does not present a detailed study report with specific acceptance criteria, performance metrics, or clinical study details as requested.

Summary

Regulation Number and Section

§ 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.