(80 days)
The CS2TM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
The indications for use are:
- A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C. Proximal femoral fractures.
- D. Avascular necrosis of the femoral head.
- E. Non-union of proximal femoral neck fractures.
- F. 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
This CS2TM hip stem is indicated for cementless use.
Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR:
- A. Primary replacement of the femoral head and neck with very little if any acetabular degradation noted.
- B. Rheumatoid, osteo, and post traumatic arthritis.
- C. Proximal femoral fractures.
- D. Avascular necrosis of the femoral head.
- E. Non-unions of proximal femoral neck fractures.
- F. Revision of failed total hip arthroplasty.
- G. Treatment of malunion or nonunion acetabular fractures.
The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.
The Consensus CS2TM Hip System (CS2HS) is a monolithic; titanium alloy fit & fill hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a cylindrical geometry with a bullet tip and is available in sizes designated as 10 mm to 22 mm. The stems feature a neck shaft angle of 128° and a 12/14. Morse taper trumilon. The stems are available with, or without a collar. The CS2 Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is. compatible with previously cleared CoCr heads, zirconia heads, Biolox delta heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.
This 510(k) summary describes a submission for a new hip stem design, the CS2™ Hip System, and primarily focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical performance data. As such, it does not detail acceptance criteria and a study proving those criteria are met in the same way a clinical trial or a performance study for an AI/ML device would.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like hip stems, "acceptance criteria" are typically related to mechanical properties, material integrity, and biological compatibility, which are demonstrated through bench testing and characterization, not performance metrics like accuracy or AUC. The "reported device performance" refers to the results of these non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength/Durability (e.g., fatigue resistance) | Bench testing of the new stem design included: |
- Distal fatigue testing
- Proximal fatigue testing of the worst-case stem.
These tests were conducted "consistent with the 'Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses'." (The specific quantitative results or pass/fail thresholds are not detailed in this summary.) |
| Porous Coating Characteristics (e.g., porosity) | CPT plasma sprayed coating characterization "meets the definition of porosity per 21 CFR 888.3358." (Specific quantitative porosity values are not detailed.) |
| Material Characterization | Based on "material, characterization data, geometry and mechanical testing" (Specific characterization data is not detailed.) |
| Substantial Equivalence to Predicate Devices | "All of the observed results indicate that the CS2 Hip System is substantially equivalent to devices currently marketed. Therefore, the device is as effective, and performs at least as safely and effectively as legally marketed predicates." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary, as it describes non-clinical bench testing. The "test set" would be the physical samples of the hip stem components subjected to mechanical and material characterization tests. The number of samples for each specific test (e.g., how many stems for fatigue testing) is not specified.
- Data Provenance: The data comes from "Non-clinical Performance Data" and "bench testing." This implies internal laboratory testing conducted by Consensus Orthopedics, Inc. (the sponsor). There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable for this type of submission. Ground truth, in the sense of expert consensus on diagnostic images or clinical outcomes, is not relevant to non-clinical bench testing of a hip implant's mechanical properties. The "ground truth" here is established by engineering standards and regulatory requirements for medical device performance.
4. Adjudication Method for the Test Set
- Not applicable as there is no "adjudication" of expert opinions for a test set. Non-clinical tests follow established protocols, and results are measured objectively against predefined engineering specifications or regulatory guidance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists, pathologists) and often for AI/ML-assisted diagnostic tools. This 510(k) pertains to a hip implant's physical and mechanical properties.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study as described is not applicable. This device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" is based on:
- Engineering Standards and Specifications: The mechanical tests (fatigue testing) were conducted "consistent with the 'Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses'." This guidance provides the framework and methodologies for evaluating the safety and effectiveness of such devices.
- Regulatory Definitions: The coating characterization "meets the definition of porosity per 21 CFR 888.3358."
- Essentially, the "ground truth" is adherence to established industry-specific test methods and regulatory requirements for proving the safety and effectiveness of a hip prosthesis.
8. The Sample Size for the Training Set
- Not applicable. There is no training set for a physical hip implant. Training sets are typically associated with machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the reason stated above.
§ 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.