(28 days)
The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures. The Metha® Hip System (uncemented, press-fit fixation) is Intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur, patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures. Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP: A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Acetabular components are indicated for cemented and cementless use.
The Consensus Acetabular Cup from Hayes Medical is a Titanium alloy shell with a highly cross linked polyethylene insert. The Consensus acetabular cups are available in 28mm, 32mm, and 36mm ID's, a variety of sizes, and in either standard or hooded versions. The shells are available with or without screws. The Aesculap Excia hip systems also comes in 28mm - 36 mm ID's, it is available in both cemented and uncemented variants, and a wide range of sizes. Aesculap's Metha hip system also comes in 28 - 36 mm ID's but is for uncemented use, and also comes in a variety of sizes. The PlasmaCup acetabular cup from Aesculap is cleared for use with both the Excia and Metha systems.
This document describes the 510(k) summary for the Consensus Acetabular Cups for use with Aesculap Excia and Metha Hip Systems. It outlines the substantial equivalence to previously cleared devices based on technological characteristics and engineering evaluation, rather than new performance data from a specific study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity for diagnostic devices; or mechanical test results for orthopedic implants) are listed in the document. The filing is based on the substantial equivalence of the device's design to existing cleared devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study yielding performance data was conducted or described in this 510(k) submission for the Consensus Acetabular Cups. The submission relies on the engineering evaluation of dimensions and the equivalence to previously cleared devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no new performance data requiring ground truth establishment from experts was generated or presented in this submission.
4. Adjudication Method
Not applicable, as no new performance data requiring adjudication was generated or presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or described. This K081978 submission is for an orthopedic implant and does not involve AI or human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is an orthopedic implant, not an algorithm.
7. Type of Ground Truth Used
Not applicable, as no primary performance study needing ground truth was performed for this submission. The basis for clearance is technological equivalence and previous clearances.
8. Sample Size for the Training Set
Not applicable. This device is an orthopedic implant, and there is no mention of a training set as would be relevant for an AI/algorithm-based device.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set or ground truth for such a set is mentioned.
§ 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.