Search Results
Found 1 results
510(k) Data Aggregation
K Number
K231109Device Name
Xerxes Hip Stem
Manufacturer
Xerxes Arthopedix LLC
Date Cleared
2023-06-15
(57 days)
Product Code
LZO, KWZ, MEH
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
Xerxes Arthopedix LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xerxes Hip Stems, when used with cleared and compatible Signature Orthopaedics hip replacement components, are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis
- Correction of functional deformity including congenital hip dysplasia
- Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement.
Xerxes Hip femoral stems are intended for cementless fixation only. The Xerxes Hip System is intended for use with Logical, World Acetabular System and Signature Orthopaedics' Femoral Heads.
Xerxes Hip when used with constrained liner components is indicated particularly for patients at high risk of hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Device Description
Xerxes™ Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Xerxes™ Hip Stem is an anatomical stem with a 5° anteversion neck and a 250 mm radius curvature on the stem body. The stem has three different surface and/or coating areas. The distal tip portion is colour anodised, polished, and rounded to aid in the insertion and avoiding distal interference. The remainder of the stem below its resection line is coated for cementless fixation. The middle portion of the stem is coated with a single layer of hydroxyapatite coating, as per ISO 13779-2 while the proximal portion is coated with an additional layer of titanium plasma spray as per ASTM F1580.
Ask a Question
Page 1 of 1