FDA classifies a shoulder-joint (hemi-shoulder) ceramic-head/metal-stem prosthesis as Class II (special controls)
The FDA classifies the shoulder joint humeral (hemi-shoulder) ceramic-head/metallic-stem (cemented or uncemented) prosthesis into Class II (special controls), stating this provides a reasonable assurance of safety and effectiveness while reducing regulatory burden and enhancing patient access to innovative devices.
Document overview (primary data)
- Document typeRule
- AgencyDepartment of Health and Human Services
- Citation91 FR 34152
Key points
- FDA classifies the hemi-shoulder ceramic-head/metal-stem prosthesis as Class II
- The applicable special controls are identified and codified
- Class II provides a reasonable assurance of safety and effectiveness
- Aims to enhance patient access to innovative devices by reducing burden
- A final order that sets the device regulatory pathway
- The device is a hemi-shoulder type with a ceramic head and metallic stem, cemented or uncemented.
FDA published a final order classifying a shoulder-joint prosthesis as a Class II (special controls) medical device.
1Hemi-shoulder prostheses with ceramic heads
The device is the humeral (hemi-shoulder) prosthesis consisting of a ceramic head and a metallic stem, used cemented or uncemented. The special controls applicable to this device type are identified in the order and become part of the codified classification language.
2How FDA device classes work
FDA's device classification is risk-based: Class I (general controls), Class II (special controls), and Class III (premarket approval). FDA determined that classifying this device into Class II provides a reasonable assurance of its safety and effectiveness. It also states the action will enhance patients' access to beneficial, innovative devices, in part by reducing regulatory burdens.
3The conditions narrowing the scope
This order does not cover shoulder prostheses generally. It narrows the scope down to the construction.
| Condition | Content |
|---|---|
| Site | The humeral side of the shoulder joint |
| Type | Hemi-shoulder |
| Head | Ceramic |
| Stem | Metallic |
| Fixation | Cemented or uncemented |
The special controls applying to this device type are identified in the order and become part of the codified classification language. Device classification governs the regulatory pathway in the US market, so for those developing or manufacturing orthopaedic implants, the class and the applicable special controls are foundational information.
Why it matters
An example of U.S. medical-device regulation (classification). For those in orthopedic implants and regulatory affairs, a useful read on the pathway and the applicable special controls.
FAQ
What is Class II?
Why classify devices?
Sources (primary)
Source: Federal Register (federal documents, public domain). Links go to the official site.