(184 days)
The Restoration® Modular Hip System is indicated for use in:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; o
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and ●
- . Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indications specific to the Restoration Modular Hip System:
The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.
The Restoration® Modular Hip System is a bowed shaped femoral distal stem which is plasmasprayed with commercially pure titanium and coated with PureFix™ hydroxylapatite (HA). The device (6276-5-6XX) is available in stem diameters 11-26 mm and length 317 mm. The design of the device is identical to the bowed plasma distal stem cleared under the predicate device 510(k)s.
A Thermoplastic Polyurethane (TPU) sleeve will be added to the previously cleared packaging configuration and the thickness of the outer carton (cardboard box) will be increased. No changes will be made to the previously cleared sterile barrier materials.
This document is a 510(k) Premarket Notification for the Restoration® Modular Hip System by Stryker Orthopaedics. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a new AI/software-based medical device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be found in this document for the Restoration® Modular Hip System.
The document explicitly states:
- "Non-clinical testing was not required as a basis for substantial equivalence."
- "Clinical testing was not required as a basis for substantial equivalence."
The "testing" mentioned in the document is related to packaging modifications and pyrogenicity for the physical device, not performance relative to clinical efficacy or diagnostic accuracy.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.