(28 days)
The Reflection Constrained Liner construct is a cemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all othe · options to constrained acetabular components have been considered.
The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.
The Re lection Constrained Liner is used with existing appropriately sized Reflection Acetabular Shells. The Reflection Constrained Liner can be used with previously implanted femoral components, femoral heads (22, 26, 28, and 32 mm) and Relection Acetabular Shells such as in a revision case, or it may be used in primary cases and implanted along with the shell, head and stem. Any appropriately sized Reflection Shell may be utilized. Any stem may be used, provided a 22, 26, 28, or 32 mm metal femoral head is used with the femoral component. Ceramic heads or skirted femoral heads of any naterial should not be used with the Reflection Constrained Liner.
This document is a 510(k) Pre-Market Notification for a medical device called the "Reflection Constrained Liner". It does not contain information about acceptance criteria, device performance, or human studies involving AI or expert review.
The document primarily focuses on establishing substantial equivalence to previously marketed devices based on:
- Intended Use: The Reflection Constrained Liner is a cemented prosthesis for hip joint replacement, indicated for primary or revision patients at high risk of hip dislocation due to specific medical conditions.
- Device Description: It describes how the liner is used with existing Reflection Acetabular Shells and various femoral components.
- Substantial Equivalence Information: It lists several predicate devices (e.g., Reflection Constrained Liner (28 mm), Johnson & Johnson S-Rom Poly-Dial Constrained Liner, Osteonics Constrained Acetabular Insert, Zimmer Triology Acetabular System).
- Summary of Technological Comparison: It states that the intended use, material, type of interface, and design features are similar to predicate counterparts.
- Supporting Documentation: It references guidance documents for Class II Special Controls, Ultra-high Polyethylene, and Testing Acetabular Cup Prosthesis.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information is not typically found in a 510(k) summary focused on demonstrating substantial equivalence for an orthopedic implant. These implant devices are cleared based on materials testing and design similarity to existing devices, not clinical performance studies with human readers or AI in the way a diagnostic imaging device would be.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”