(55 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 Hip System components are intended for single use only and are to be implanted without bone cement.
Subject of this Abbreviated premarket notification is the addition of a new stem design to the Smith & Nephew REDAPT™ Revision Femoral System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789 and the Modular Sleeved Revision Hip Stems cleared by K121627. The proposed devices are REDAPT Sleeveless Monolithic Revision Stems, new hip stems that will be marketed as part of the REDAPT Revision Femoral System.
The REDAPT Sleeveless Monolithic Revision Stems are a modification of the primary predicate REDAPT Modular Proximally Fluted Hip Stem and reference predicate REDAPT Modular Sleeved Revision Hip Stem. The Sleeveless Monolithic Revision Stem is very similar to the predicate REDAPT hip stems in that it is a tapered, distally fixed femoral stem that is manufactured from forged titanium allov (Ti-6Al-4V) and has a grit blast finish. The subject device will be available in lengths of 190mm, 240mm, and 300mm and sizes 12-27, in 1mm increments. The REDAPT Sleeveless Monolithic Hip Stems will feature a non-modular, fixed neck with a 12/14 taper.
This document is a 510(k) premarket notification for a medical device, the Smith & Nephew REDAPT™ Revision Femoral System. Such notifications typically aim to demonstrate substantial equivalence to previously cleared devices rather than prove performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria and clinical study details is not present in this type of regulatory submission.
However, based on the provided text, I can infer and state the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific acceptance criteria (e.g., specific thresholds for wear, fatigue life, or other mechanical properties) for the REDAPT™ Sleeveless Monolithic Revision Stems, nor does it typically report detailed device performance metrics against such criteria in this format. Instead, it refers to performance testing conducted in accordance with guidance documents.
The document indicates that the device has undergone performance testing. The "reported device performance" in this context is that the device met the requirements of the referenced tests, thereby demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to "Non-Clinical Information for Femoral Stem Prostheses, dated September 2007" | Performance testing conducted and demonstrates no new issues related to safety or effectiveness. |
| Conformity to "Draft Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, dated May 1995" | Performance testing conducted and demonstrates no new issues related to safety or effectiveness. |
| Sufficient Fatigue Strength | Fatigue strength evaluated and demonstrates no new issues related to safety or effectiveness. |
| Sufficient Range of Motion | Range of motion testing evaluated and demonstrates no new issues related to safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail the sample sizes used for performance testing (e.g., the number of stems tested for fatigue strength). These are typically bench tests rather than clinical studies.
The "data provenance" mentioned refers to non-clinical, mechanical, and material testing data, not human patient data. Therefore, concepts like country of origin of data (for patients) or retrospective/prospective do not apply here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for mechanical testing is established by engineering standards, test methods, and material properties, not by expert medical consensus, as no human data is involved in this document.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretation of medical images or patient outcomes. This document discusses bench testing of a medical implant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the premarket notification for a
hip prosthetic stem, which involves mechanical and material testing, not an MRMC study comparing human reader performance with and without AI assistance for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document pertains to a physical medical device (hip implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the REDAPT™ Revision Femoral System components would be engineering specifications, material standards, and benchmark performance of predicate devices under the conditions outlined in the referenced guidance documents and test methods (e.g., specific load cycles for fatigue testing, displacement limits for range of motion).
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical hip implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.