(461 days)
The DePuy Corail Revision Stem is indicated for cementless use in the treatment of:
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
- Avascular necrosis of the femoral head;
- Acute traumatic fracture of the femoral head or neck;
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
- Certain cases of ankylosis.
The subject Corail Revision Stem is intended for cementless use as part of the femoral component in a total hip arthroplasty.
The Corail Revision Stem is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral heads which articulate with DePuy acetabular systems with either a metal or UHMPE liner. The Corail Hip System, Revision Stem is a line addition to the Corail hip stem family. The stems are available in 9 lengths in sizes 10-20 in standard and high-off versions. The subject titanium alloy hip stems are monolithic, grit blasted stems plasma sprayed with hydroxyapatite powders on the entire stem length. The stems feature a 12/14 AMT (Articul/eze Mini Taper) Taper trunnion which are compatible with previously cleared metal and ceramic DePuy femoral heads with corresponding 12/14 tapers and offsets up to +13 mm.
This 510(k) summary (K093736) describes the DePuy Corail® Hip System, Revision Stem.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it indicates that "All of the observed results indicate that the Corail Revision Hip System is substantially equivalent to devices currently marketed." This implies that the performance matched or exceeded what is considered acceptable for the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in: | Substantially equivalent to predicate devices in intended use, indications for use, materials, geometry, design, and performance. |
| Non-clinical testing results for: | Bench testing (Range of Motion, proximal fatigue, ceramic head compatibility) and coating characterization were provided. |
| Coating thickness and application | Nonporous, calcium phosphate coating applied by plasma spraying to a nominal thickness of 155 ± 35 microns from hydroxyapatite powders. |
(Note: The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than setting specific numerical performance targets that need to be met independently for a novel technology.)
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not applicable. This submission relies on substantial equivalence and non-clinical testing, not a clinical test set with patient data.
- Data Provenance: Not applicable. The testing was non-clinical bench testing and coating characterization.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable. No clinical test set with ground truth established by experts was used.
4. Adjudication Method (Test Set)
Not applicable. No clinical test set with an adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical testing was required to demonstrate substantial equivalence." This type of study would involve human readers and clinical data, which was not part of this submission. Since no such study was performed, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a medical implant (hip stem), not an AI algorithm. Therefore, a standalone performance study of an algorithm was not conducted.
7. Type of Ground Truth Used
Not applicable. For this device, ground truth as typically understood in AI/imaging studies (e.g., expert consensus, pathology, outcomes data) was not established from clinical data. The demonstration of safety and effectiveness was based on non-clinical testing and substantial equivalence to predicate devices.
8. Sample Size for Training Set
Not applicable. This device is a medical implant, not an AI algorithm. There is no concept of a "training set" in this context.
9. How Ground Truth for Training Set Was Established
Not applicable. As this is not an AI algorithm, there was no training set or ground truth to establish for training purposes.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.