(280 days)
The VitalitE Acetabular Insert for the Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:
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
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.
The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).
The provided text describes the 510(k) premarket notification for the VitalitE Acetabular Insert for the CS2™ Acetabular Cup System. The submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the VitalitE Acetabular Insert to be evaluated against in a clinical study. Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. The performance data is primarily "Non-Clinical Performance Data."
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated as Numerical Criteria) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Material Equivalence | "The vitamin E poly used in the new Consensus CS2 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level)." | The new VitalitE Acetabular Insert uses a vitamin E cross-linked UHMWPE material that is "identical" to that used in cleared predicate devices (K094035, K122773), with a noted exception in radiation dosing. |
| Design Equivalence | "The new VitalitE Acetabular Insert for the CS2 Acetabular Cup System is identical in design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 510(k)s: K021466, K070061, and K100933." | The design of the new insert is "identical" to previously cleared cross-linked UHMWPE acetabular inserts (K021466, K070061, K100933). |
| Bench Testing Performance | Implied criteria for wear, push-out, and torque-out performance at least as safe and effective as predicates. (Specific numerical criteria not given) | "Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new stem design included wear testing of the worst case acetabular insert, in addition to disassembly testing which included push-out, and torque-out tests." "All of the observed results indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed." |
| Biocompatibility | Implied criteria for biocompatibility at least as safe and effective as predicates. (Specific criteria not given) | Biocompatibility testing was performed and included in the overall assessment of substantial equivalence. |
| Overall Safety & Effectiveness | "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." | Based on material, characterization data, geometry, and mechanical testing, the device is deemed "substantially equivalent" and thus "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a "test set" of patient data. The "testing" mentioned is entirely non-clinical (bench testing, material characterization, and biocompatibility). Therefore, there is no sample size for a test set or data provenance (country of origin, retrospective/prospective) related to patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Since no clinical study involving patient data was conducted to establish ground truth, no experts were used for this purpose.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device requiring interpretation by human readers. It is a medical implant, and the submission focuses on its physical and material properties.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is not a software algorithm device. It is a physical medical device (an acetabular insert).
7. Type of Ground Truth Used:
Ground truth in the typical sense of clinical outcomes or expert consensus for patient data is not used in this submission. The "ground truth" here is established through:
- Material properties: Chemical composition and physical characteristics of the UHMWPE.
- Design specifications: Geometric and structural adherence to established designs.
- Bench test results: Mechanical performance (wear, push-out, torque-out) measured against engineering standards or comparison to predicate device performance under similar test conditions.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set was used.
Summary of the Study:
The "study" described in K130652 is a non-clinical substantial equivalence submission. It relies on:
- Comparison of material properties: The vitamin E polyethylene is stated to be "identical" to material in already cleared devices.
- Comparison of design: The new insert's design is "identical" to previously cleared inserts.
- Bench testing: Wear testing of the "worst-case acetabular insert" and disassembly testing (push-out, torque-out) were performed. The results are not detailed but are stated to "indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed."
- Biocompatibility testing: Mentioned as part of the non-clinical data.
The "study" concludes that based on these non-clinical evaluations, the device is "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." This approach is typical for 510(k) clearances when a new device is fundamentally similar to existing, legally marketed devices.
§ 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.