(133 days)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Smith & Nephew Redapt Revision Femoral System components are intended for single use only and are to be implanted without bone cement.
The Redapt Revision Femoral System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete Redapt Revision Femoral System construct. Subject of this Abbreviated premarket notification are the Redapt Modular Sleeved Revision Hip Stems and size 26/27 Modular Sleeves. The Modular Sleeved Revision Hip Stem is a modification of the MDF Revision Hip Stem cleared via premarket notification K081124. The Modular Sleeved Revision Hip Stem is a straight, tapered, distally fixed, modular stem. The subiect device is manufactured from titanium alloy (Ti-6Al-4V), has a grit-blast finish, and is available in lengths of 240mm and 300mm in sizes 11-27. The Modular Sleeved Revision Hip Stems has a modular 12/14 female neck taper that mates with the cobalt chrome modular necks previously cleared in premarket notification K0811124.
The size 26/27 Modular Sleeves are line additions to the Modular Sleeves cleared in K081124. The subject devices lock onto the proximal end of the stem to aid in proximal fixation. The size 26/27 Redapt Modular Sleeves are identical in design to the current modular sleeves cleared by K081124 and are also offered in the same small, medium, and large cone sizes. The subject devices are proportionally larger to accommodate the size 26/27 stems. The subject devices contain the Smith & Nephew Stiktite coating. A Hydroxyapatite (HA) coating will be applied to the Stiktite coated areas of the size 26/27 Redapt Modular Sleeves.
This submission describes a medical device, the Smith & Nephew Redapt® Revision Femoral System, and its substantial equivalence to a previously cleared predicate device (K081124). As such, it does not describe an AI/ML device or a study involving human readers. Therefore, several requested sections are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical "acceptance criteria" for performance in the typical sense of an AI/ML device. Instead, it relies on demonstrating substantial equivalence to a predicate device and meeting performance testing standards for orthopedic implants. The "reported device performance" is essentially the successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant guidance documents for orthopedic implants | "Performance testing has been conducted for the subject devices in accordance with the following guidance documents: Non-Clinical Information for Femoral Stem Prostheses, dated September 2007; Draft Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, dated May 1995; Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, dated April 1994; Calcium Phosphate (Ca-P) Coating Draft Guidance Document for Preparation of FDA Submissions for Orthopaedic and Dental Endosseous Implants, dated February 1997." |
| Passage of specific mechanical tests | "Environmental corrosion fatigue, pre-fatigue and post-fatigue pull-off, and fatigue strength testing were performed. The range of motion of the Modular Sleeved Revision Hip Stem was also evaluated." |
| No new safety or effectiveness issues compared to predicate | "A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." |
| Substantial equivalence to predicate device (K081124) in materials, intended use, indications, sterilization, and overall design | Confirmed by FDA clearance and detailed comparison in Table 1 (which shows identical or proportionally larger versions of the predicate's components with the same materials and design philosophy). |
2. Sample Size Used for the Test Set and Data Provenance
This is a materials science and mechanical engineering performance study of physical orthopedic implants, not a study involving a "test set" of data in the AI/ML sense. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable. The testing would have involved a specific number of manufactured components designed for mechanical and material property evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for an AI/ML system is irrelevant for this type of medical device submission, which focuses on the physical properties and safety of an implant. The "ground truth" here is established by engineering standards and validated testing protocols.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of an AI/ML model being evaluated by experts.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic assist AI/ML devices, not for physical orthopedic implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an algorithm or AI/ML device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is established through objective engineering standards, validated testing methodologies, and material specifications (e.g., ASTM standards for materials and testing). It's based on physical measurements and performance under controlled conditions, not on clinical expert consensus, pathology, or outcomes data in the sense of an AI diagnosis. The document states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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.