Shoulder Prosthesis Joins Class II Regulatory Tier
Published Date: 6/5/2026
Rule
Summary
The FDA is officially putting the shoulder joint humeral ceramic head/metallic stem prosthesis into Class II, meaning it now has special safety rules but fewer red tape hurdles. This change helps patients get safer, innovative shoulder implants faster and makes life easier for makers by lowering regulatory costs. The new classification is effective June 5, 2026, but has been in effect since December 16, 2022.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Hemi‑shoulder implant moved to Class II
If you need a shoulder humeral (hemi‑shoulder) implant, the FDA has classified the ceramic head/metallic stem prosthesis as Class II (special controls). The final order is effective June 5, 2026 and was applicable on December 16, 2022; FDA says this classification provides a reasonable assurance of safety and is intended to enhance patient access to innovative shoulder implants by reducing regulatory burdens.
Device now subject to 510(k) pathway
Manufacturers of this shoulder hemi prosthesis must submit a premarket notification under section 510(k); FDA has not exempted this device under section 510(m) of the FD&C Act. The device’s Class II status means sponsors can use the 510(k) process rather than premarket approval (PMA).
New special controls manufacturers must meet
Manufacturers must meet the special controls codified at 21 CFR 888.3695, including clinical data on shoulder function and adverse events; non‑clinical performance testing (mechanical fatigue, fretting/corrosion, static strength, modular disassembly strength, wear analysis, and worst‑case range of motion); biocompatibility for all patient‑contacting components; sterility and pyrogenicity performance data; validation of reprocessing instructions for reusable components; shelf‑life data demonstrating sterility and package integrity; and labeling with validated reprocessing methods and a shelf life.
De Novo classification creates a predicate
Because FDA classified this device via the De Novo process, the device can serve as a predicate for future devices of that type; other sponsors can rely on this predicate to use the 510(k) process rather than submitting a De Novo request or a PMA.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-18432, Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18426, Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18433, Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
The FDA is officially classifying a new device that protects the esophagus during heart procedures as a Class II device, meaning it’s safe and effective with some special rules. This change helps patients get access to this cool innovation faster by cutting down on red tape. The new classification took effect on September 10, 2026, but has been in place since September 6, 2023, making it easier and potentially cheaper for makers to bring this device to market.
Previous / Next Documents
Previous: 2026-11304, Establishment of Class E Airspace; Wickenburg, AZ
Starting September 3, 2026, new Class E airspace will be set up around Wickenburg, Arizona to help pilots fly safely using instruments, especially when the weather isn’t great. This change mainly affects pilots and air traffic controllers by improving flight rules and procedures in the area. No extra costs for the public, just smoother and safer skies!
Next: 2026-11307, Amendment of Class E Airspace; Springfield, KY
The FAA is updating the Class E airspace around Lebanon Springfield Airport in Springfield, KY, to match new flight procedures and correct the airport’s name and location info. This change helps pilots fly safely using instruments and kicks in on September 3, 2026. No extra costs for anyone—just smoother skies and clearer rules!