OMNI ARC Anteverted Neck Hip Stem

• K Number: K172467
• Device Name: OMNI ARC Anteverted Neck Hip Stem
• Manufacturer: OMNIlife science
• Date Cleared: 2017-12-21 ( 128 days)
• Product Code: LZO
• Regulation Number: 888.3353
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K133381

Intended Use

The OMNI ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Congenital dislocation;
• · Revision procedures where other treatments or devices have failed;
• · Femoral neck and trochanteric fractures of the proximal femur.

The OMNI ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

Device Description

The proposed devices are intended to be used for primary and revision total hip replacement.

The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed.

The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136)

AI/ML Overview

This document describes the regulatory submission for the "OMNI ARC Anteverted Neck Hip Stem." It is a 510(k) premarket notification, which means the manufacturer is seeking to demonstrate that their new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch through extensive clinical trials.

Therefore, the typical questions about acceptance criteria for device performance, a study proving the device meets those criteria, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable in the context of this 510(k) submission.

Here's why and what information is provided:

1. Acceptance Criteria and Reported Device Performance:

• Not Applicable in the traditional sense of a clinical performance study. The submission focuses on demonstrating substantial equivalence to a predicate device (K133381 OMNI ARC Monoblock Hip Stem).
• Performance is inferred through justification of equivalence. The "performance" assessment is based on demonstrating that the new design (anteverted neck options) does not introduce new risks and functions similarly to the predicate. The document states: "The proposed devices with modifications are substantially equivalent to the existing OMNI ARC Monoblock Hip Stem cleared in K133381 as the basic design, interface, fundamental technology, materials and intended use are the same."

2. Sample Size and Data Provenance:

• Not Applicable. No clinical test set data from patients is described or required for this type of 510(k) submission, as it relies on substantial equivalence to a known predicate rather than new clinical data.
• The "data" here refers to engineering evaluations and justifications, not patient data. The document mentions "HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck" and "HTR-099 ARC Monoblock Anteverted Neck ROM" as justifications. These are likely finite element analysis (FEA) and range of motion (ROM) studies, which are engineering simulations/tests typically performed in vitro or computationally, not on patient samples.

3. Number of experts and qualifications for ground truth:

• Not Applicable. As no clinical test set data from patients is being evaluated for ground truth, there are no medical experts determining a "ground truth" for diagnostic or predictive performance. The "experts" would be the engineers and designers involved in proving equivalence through design, materials, and mechanical testing.

4. Adjudication Method:

• Not Applicable. No clinical data to adjudicate.

5. MRMC Comparative Effectiveness Study:

• Not Applicable. This is a medical device (hip stem), not an AI/diagnostic algorithm that would assist human readers in interpretation.

6. Standalone Performance:

• Not Applicable. No standalone algorithm performance is relevant for a physical implantable device.

7. Type of Ground Truth Used:

• Based on engineering principles and predicate device performance. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device (K133381 OMNI ARC Monoblock Hip Stem), combined with engineering analyses (like FEA) demonstrating that the modifications do not negatively impact these characteristics.

8. Sample Size for Training Set:

• Not Applicable. There is no "training set" in the context of a physical medical device. The "training" for the device's design is based on established biomechanical principles, material science, and the performance characteristics of the predicate device.

9. How Ground Truth for Training Set was Established:

• Not Applicable. See point 8.

In summary, for this specific 510(k) submission (K172467):

The manufacturer, OMNIlife Science, Inc., is seeking to market the "OMNI ARC Anteverted Neck Hip Stem" by demonstrating its substantial equivalence to an already legally marketed device, the "OMNI ARC Monoblock Hip Stem" (K133381). This type of submission relies on showing that the new device's design, materials, and intended use are fundamentally the same as its predicate and that any modifications (adding anteverted neck options) do not introduce new safety or effectiveness concerns.

Instead of clinical performance data, the submission relies on:

• Comparison of Indications for Use: The Indications for Use for the OMNI ARC Hip Stem are listed on page 2 and are expected to be similar or identical to the predicate device.
• Device Description Comparison: The new device offers anteverted neck options, but its design is "similar to the ARC Monoblock stem designs currently marketed." The material (Ti-6Al-4V E.L.I) is also stated.
• Justifications/Evaluations: The submission mentions specific justifications like "HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck" and "HTR-099 ARC Monoblock Anteverted Neck ROM." These are engineering analyses (likely computational or bench testing) used to support the claim that the modifications do not introduce new risks regarding fatigue life or range of motion compared to the predicate. No clinical testing data is presented or required for a 510(k) based solely on substantial equivalence via design modifications and engineering justification.

Regulation Number and Section

§ 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.