(102 days)
The HELICON™ Hip System is designed for total hip arthroplasty.
The indications for use are:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- Proximal femoral fractures.
- Avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
The HELICON™ hip stem is indicated for cementless use. The HELICON™ acetabular shell component is indicated for cemented or cementless use.
The HELICON Hip System (HHS) is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The HHS includes a femoral stem, a CoCr femoral head, non-crosslinked UHMWPE insert, acetabular shell and bone screws.
The HHS stem is a monolithic, titanium alloy, tapered hip stem available with a proximal CPTi plasma porous coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes ranging from 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. HHS stems are compatible with the HHS CoCr femoral head and HHS acetabular insert. The HHS CoCr head is highly polished and available in multiple offsets and diameters (22, 28, and 32mm). The HHS acetabular components include a titanium alloy shell and a mating UHMWPE insert. The shell is a hemispherical design, is available with or without screw holes, and employs a CPTi beaded, porous coating. The UHMWPE insert is available in 20° hooded or nonhooded (neutral) configurations in inner diameters of 22, 28, and 32mm. Titanium alloy bone screws are available for additional fixation.
The provided text describes a Premarket Traditional 510(k) Notification for the HELICON Hip System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this type of submission. The submission explicitly states: "No additional nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials." and "All of the observed results for the predicate TaperSet Hip System had been found substantially equivalent prior to devices currently marketed. The subject Helicon Hip System is identical in material and design to that of the TaperSet Hip System."
Below is an attempt to address the request based on the information provided, highlighting where information is not applicable due to the nature of a 510(k) for substantial equivalence.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The HELICON Hip System (HHS) demonstrates acceptance by establishing substantial equivalence to legally marketed predicate devices. This means that its acceptance criteria are implicitly those that the predicate devices met, and the "study" proving this is a comparative analysis against the predicates across various technological characteristics and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on identical design and materials to predicates, the acceptance criteria are inferred to be the performance standards met by the predicate devices. The reported device performance for HHS is asserted to be identical to these predicates due to the "identical material, characterization data, geometry and mechanical testing."
| Acceptance Criteria (Inferred from Predicates) | Reported Device Performance (for HELICON Hip System) |
|---|---|
| Material Composition: Identical material specifications (e.g., Titanium alloy, CoCr, UHMWPE) as predicate components. | Identical: HHS implant components use identical materials as predicate components (TaperSet Hip System femoral stem, CoCr femoral heads, UHMWPE inserts, acetabular shell, bone screws). |
| Design Geometry: Identical design construct features, including dual wedge geometry, neck shaft angle (135°), Morse taper trunnion, hemispherical shell design, etc., as predicate components. | Identical: HHS implant components use identical design construct features as predicate components (e.g., locking mechanisms of the polyethylene insert to the metal shell and the exterior coatings). |
| Mechanical Performance: |
- Distal and proximal stem fatigue testing (worst-case stem).
- Range of Motion analysis.
- CPTi plasma sprayed and CPTi beaded metallic coating characterization (per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement").
- CPTi plasma spray characterization (per "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants...").
- Polyethylene insert retention mechanism testing.
- Bone screw mechanical strength testing.
- Modular connection analyses (fretting and corrosion of metallic femoral heads).
- Pin-on-flat testing of non-crosslinked UHMWPE/CoCr material combination. | Met by Predicate Devices; Asserted for HHS: All predicate bench testing results, covering the items listed in the criteria, were found substantially equivalent and are directly applicable to HHS due to identical design and materials. "No additional nonclinical bench testing was deemed necessary." "Therefore, the subject device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." |
| Porous Coating Definition: CPTi plasma sprayed coating and CPTi beaded coating characterizations meet regulatory definition of porous coating for hip construct per 21 CFR 888.3358. | Met by Predicate Devices; Asserted for HHS: Both the CPTi plasma sprayed coating and the CPTi beaded coating characterizations meet the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358. |
| Indications for Use: Consistent with the indications for use of the predicate devices. | Consistent: The indications for use for the HHS are identical to those of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. There was no new "test set" in the traditional sense for the HELICON Hip System. The assessment relies on the existing performance data and characterizations of the predicate devices.
- Data Provenance: The data provenance is from the non-clinical bench testing conducted for the predicate devices, specifically those associated with Consensus Orthopedics, Inc. (COI) and U.S. Medical Products, Inc. This would be retrospective as the testing has already been completed and reviewed by the FDA for the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission does not involve a clinical study requiring expert ground truth for a test set. The "ground truth" for the performance of the HELICON Hip System is established by its direct identity in materials and design to the already cleared predicate devices, whose performance characteristics were previously vetted by the FDA through their own respective 510(k) clearances.
4. Adjudication Method for the Test Set
Not applicable. There was no new test set requiring adjudication in this 510(k) submission.
5. 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 device is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" is based on the non-clinical bench testing results and material/design characterization data from the predicate devices. This data was previously accepted by the FDA as sufficient to demonstrate the safe and effective performance of those predicate devices. For the HELICON Hip System, the ground truth is its identicality to these well-characterized predicates.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an orthopedic implant 510(k) submission based on substantial equivalence to predicates.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this type of device submission.
§ 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.