21 CFR 888.3900 — Limb And Joint Salvage Device With Coating For Bacteria Reduction
Orthopedic (OR) · De Novo Classifications · § 888.3900
Identification
A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device, intended to reduce microbial contamination on the surface of the device prior to implantation.
Classification Rationale
Class II (special controls). The device is classified as Class II because it is a limb and joint salvage device with a quaternary ammonium compound coating, and the identified risks to health can be mitigated by general controls and the specified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 2 | 2 | Implant |
Special Controls
QZZ — Limb And Joint Salvage Device With Coating For Bacteria Reduction
In combination with the general controls of the FD&C Act. the limb and joint salvage device with quaternary ammonium compound coating is subject to the following special controls: - (1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Animal testing must include imaging, histology. and histomorphometry to assess bone formation, healing, and tissue response at relevant timepoints over the course of healing. - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: - Evaluation of the static and dynamic performance of the implant: (i) - Evaluation of coated implant initial fixation: (ii) - Evaluation of coating integrity: (iii) - Evaluation of range of motion; (iv) - Evaluation of articulating bearing wear and bearing material; (v) - Evaluation of implant disassembly: (vi) - (vii) Evaluation of fretting and corrosion; - (viii) Evaluation of antimicrobial performance with clinically relevant microbial species; and - (ix) Coating characterization, including a detailed description of the substrate morphology and coating process and an evaluation of coating physicochemical properties such as density, thickness, chemistry, and uniformity. - (3) An analysis must be provided that identifies and evaluates any contribution to the development and spread of antimicrobial resistance. - (4) An analysis or information must be provided to support that the antimicrobial does not act within or on the body. - (5) The patient-contacting components of the device must be demonstrated to be biocompatible. - (6) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile. - Performance data must validate the reprocessing instructions for the reusable (7) instrumentation to be used with the device. - Performance data must support the shelf life of the device by demonstrating continued (8) sterility, package integrity, and device functionality over the identified shelf life. - (9) Labeling must include the following: - Identification of device materials; (i) - A shelf life: and (ii) - (iii) Instructions for removal/revision procedures.
De Novo Order DEN210058
