(43 days)
The Pipeline Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured (PST™) surface provides biological fixation when used in a cementless application.
The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.
This 510(k) addresses the addition of the following components (already cleared under 510(k) #K122158) to the Pipeline Total Hip System:
- . HA-coated Acetabular Shells feature a thin HA coating applied over the porous structured (PST) shells in a range of sizes,
- . Biolox® delta Ceramic Femoral Heads available in a range of diameters and extension options,
- . 40mm CoCr Femoral Heads, and
- . 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners.
These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K112802 and as the PBP Total Hip System in 510(k) #K122158.
The provided text describes a Special 510(k) Premarket Application for a line extension to the "Pipeline Total Hip System." This type of submission claims substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" and "study" described are not for a de novo device, but rather the justification for substantial equivalence.
Here's how the information aligns with your request:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this 510(k) is substantial equivalence to predicate devices. The reported "performance" is that the new components are identical to those already cleared.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate K122158 | The HA-coated Acetabular Shells, Biolox® delta Ceramic Femoral Heads, 40mm CoCr Femoral Heads, and 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners are identical to the same components cleared under 510(k) #K122158. |
| No difference in key characteristics | There is no difference in intended use, materials, design features, component sizing, or manufacturing methods compared to the predicate devices cleared in K122158. The only difference is the subsidiary name under which they are marketed. |
| Compatibility with existing system | The new components are compatible with the Pipeline Total Hip System (cleared in K112802) and the PBP Total Hip System (cleared in K122158). |
| Indicated Use Match | The intended use for the line extension components matches the intended use of the Pipeline Total Hip System, which includes conditions like osteoarthritis, traumatic arthritis, avascular necrosis, congenital hip dysplasia, acute traumatic fracture, and failed previous hip surgeries. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the traditional sense of clinical or performance data for a new device. Instead, the "test" is a comparison to existing, cleared devices on the market. The submission asserts that the components are identical to those previously cleared. Therefore, there's no independent sample size or data provenance to report for a specific "test set." The "provenance" for the predicate devices would be based on the information provided in their respective 510(k) submissions (K112802 and K122158), which is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a claim of identicality to cleared devices, not a study requiring expert-established ground truth for a new device's performance. The "ground truth" here is the prior FDA clearance of the identical components.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring adjudication in this type of 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 hip replacement system, not an AI-assisted diagnostic or imaging tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical hip replacement system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the prior FDA clearance and determination of substantial equivalence for the identical components under 510(k) #K122158. The submission argues that since the new components are identical to those previously cleared, their safety and effectiveness are established by the predicate's clearance.
8. The Sample Size for the Training Set
Not applicable, as this is a mechanical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is a mechanical device, not a machine learning algorithm.
§ 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.