Bone Screws dia. 5,0 mm
by Lima Corporate S.P.A. 510(k)
Active
510(k) K210717
Overview
The Bone Screws dia. 5,0 mm are fixation components designed for use with the SMR TT Augmented 360 Baseplate. These screws provide mechanical fixation of the glenoid baseplate to the bone during reverse shoulder arthroplasty procedures.
This device is part of the modular SMR Shoulder System and is intended for use by surgeons in clinical orthopedic settings. The device has received FDA 510(k) clearance under K210717.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210717 | Date12 Jul 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- PHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Lima Corporate S.P.A.
Questions
What is the primary clinical application for these bone screws?
These 5.0 mm bone screws are specifically designed to provide mechanical fixation of the glenoid baseplate to the bone. They are intended for use during reverse shoulder arthroplasty procedures as part of the modular SMR Shoulder System.
Are these screws compatible with all shoulder systems?
No, these screws are specifically engineered for use with the SMR TT Augmented 360 Baseplate. They are a component of the modular SMR Shoulder System and should only be used in the clinical orthopedic settings for which they were designed.
What is the regulatory status of the 5.0 mm Bone Screws?
The device has received FDA 510(k) clearance under K210717. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended use in orthopedic surgery.