(190 days)
TaperFit Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip revision.
The TaperFit Hip Stem is indicated for cemented, single use only.
The Corin TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone CoCrMo modular femoral heads (K003666). The stem is currently available in sizes, 1 through 4 with 2 offsets 45mm and 38mm, as well as a CDH option with a 36mm offset.
The purpose of this submission is to add the 1-hole design of the TaperFit Hip Stem to the TaperFit range. This new design has a single rounded elliptical dove-tail hole on the lateral shoulder of the stem for the stem introducer, instead of 2 rounded or angulated introducer holes which the predicate devices have. In addition to the change in introducer hole design, this 510(k) adds size 0 stems to the 38mm and 45mm offsets, and sizes 0 through 4 in a 50mm offset.
The submission is also to modify the labeling for the TaperFit Hip Stem to add the previously cleared Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) as compatible components, intended for use with the TaperFit Hip Stem.
The provided text is a 510(k) summary for a medical device called the "Corin TaperFit Hip Stem." This document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it explicitly states that clinical testing was not necessary to determine substantial equivalence. Therefore, the document does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance.
For this type of device, the acceptance criteria and proof of meeting them are primarily based on non-clinical testing and comparison to predicate devices, rather than human clinical trials.
Here's a breakdown of the requested information based on the provided text, highlighting where data is unavailable for clinical performance:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a table of clinical acceptance criteria because no clinical study was performed. The acceptance criteria instead relate to the equivalence to predicate devices based on non-clinical testing.
| Acceptance Criterion (Implied Non-Clinical) | Reported Device Performance |
|---|---|
| Material Equivalence | Manufactured from stainless steel in accordance with ISO 5832-9. Same materials as predicate Corin Taper-Fit Hip Stem (K992234 and K003666). |
| Design Equivalence (New Features) | - 1-hole design for stem introducer (instead of 2 rounded or angulated holes on predicate devices). |
- Adds size 0 stems to 38mm and 45mm offsets.
- Adds sizes 0 through 4 in a 50mm offset.
- Otherwise noted as "similar in design" to predicate devices. |
| Intended Use/Indications Equivalence | Same intended use and indications as predicate Corin Taper-Fit Hip Stem (K992234 and K003666). |
| Mechanical Performance (Non-Clinical) | Results of FEA, mechanical fatigue testing, static tensile testing, rotational torque testing, and range of motion testing showed the device is "expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices." (Specific performance metrics and thresholds are not detailed in this summary). |
| Compatibility Equivalence | Modified labeling to add previously cleared Trinity Acetabular System as compatible components. |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for clinical performance. The document explicitly states "Clinical testing was not necessary." For non-clinical testing, specific sample sizes for mechanical tests (FEA, fatigue, tensile, rotational torque, range of motion) are not detailed in this summary. The provenance of the data is implied to be from Corin USA's internal non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided for clinical performance. No clinical test set was used for ground truth establishment.
4. Adjudication method for the test set
Not applicable/Not provided for clinical performance. No clinical test set was used.
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 hip stem implant, not an AI-assisted diagnostic tool or imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
Not applicable for clinical ground truth. For the non-clinical testing, the "ground truth" would be established by engineering standards, material specifications (ISO 5832-9), and established biomechanical test methodologies to demonstrate equivalence to predicate devices and acceptable performance under simulated physiological conditions.
8. The sample size for the training set
Not applicable. No clinical training set was used for this device.
9. How the ground truth for the training set was established
Not applicable. No clinical training set was used.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.