Rule 2026-11306

FDA classifies a shoulder-joint (hemi-shoulder) ceramic-head/metal-stem prosthesis as Class II (special controls)

Health and Human Services Department ・Published Jun 5, 2026 ・91 FR 34152

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
AgencyHealth and Human Services Department
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

FDA published a final order classifying a shoulder-joint prosthesis as a Class II (special controls) medical device.

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.

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.

Device classification determines the U.S. regulatory pathway (the required procedures and controls). For developers and manufacturers of orthopedic implants, the class and applicable special controls are foundational to product development and market entry.

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?

FDA's moderate-risk device category requiring special controls in addition to general controls — between Class I (low) and Class III (high, premarket approval).

Why classify devices?

To set the appropriate regulatory pathway and controls per device, assuring safety while avoiding excessive burden to speed market entry.

Sources (primary)

Source: Federal Register (federal documents, public domain). Links go to the official site.

#FDA#Medical device#Orthopedics#Class II#Regulatory classification

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