(90 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 (NID) 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; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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.
The Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Subject of this Abbreviated Premarket Notification are line additions to the R3 Acetabular System. The line additions consist of R3 Multi-Hote Shells and 36mm XLPE Acetabular Liners.
This document K092386 is a 510(k) summary for R3 Multi-Hole Shells and 36mm XLPE Acetabular Liners. It is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, rather than establishing acceptance criteria through a study demonstrating device performance against specific metrics.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document describes:
- Device Description: Line additions to the R3 Acetabular System.
- Intended Use and Indications For Use: Broad medical conditions for which the hip components are indicated.
- Substantial Equivalence: Lists predicate devices to which the current device is considered equivalent.
The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily on proving that it meets specific numeric performance acceptance criteria through a new clinical or laboratory study with a predefined sample size, expert ground truth, or adjudication methods for that specific study. While testing (e.g., mechanical testing for orthopedic implants) is typically performed to ensure safety and effectiveness and may be summarized, the detailed structure of acceptance criteria and the study as requested (including sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not part of this 510(k) summary.
§ 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.