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The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The LINEAGE® HA Acetabular Shells are intended for single patie

A Hydroxylapatite (HA) coating is being added to the LINEAGE® Acetabular Shells previously cleared for market in the US.
The LINEAGE® HA Acetabular Shells are single use components, intended for use as part of an uncemented total hip arthroplasty system; in conjunction with WMT's poly or metal liners; and ceramic or metal femoral heads.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device, the LINEAGE® HA Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary lists:

• Submitted By: Wright Medical Technology, Inc.
• Date: November 06, 2004
• Proprietary Name: LINEAGE® HA Acetabular Shells
• Common Name: Acetabular Shells
• Classification Name and Reference: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate - Class II (21 CFR 888.3358); Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Class II (21 CFR 888.3330); Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis - Class III
• Device Product Code and Panel Code: Orthopedics/87/MEH/LPH/KWA
• Intended Use: Total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with specified conditions including non-inflammatory and inflammatory degenerative joint disease, correction of functional deformity, revision procedures, and treatment of nonunion/fractures of the proximal femur.
• Device Description: A Hydroxylapatite (HA) coating is added to previously cleared LINEAGE® Acetabular Shells.
• Substantial Equivalence Information: The device is claimed to be substantially equivalent to predicate devices previously cleared for market. Safety and effectiveness are "adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification."

The acceptance criteria and study details requested in the prompt are not present in the provided text. The document states that "testing results" were provided, but it does not elaborate on what those tests were, their acceptance criteria, or their outcomes. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria as might be found in a PMA.

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