# K161120: SMR TT Metal Back Glenoid, Bone Graft instruments

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Feb 21, 2017 after 306 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911686 (1991). 90 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 93 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133349: SMR TT Metal Back Glenoid, Lima Corporate S.P.A. (2014) Summary page 4.

## Most influential descendants
- K172456: Bone Screws 6.5mm (2018), 1 descendant of its own
- K183042: SMR Lateralized Connectors with screws (2019), 0 descendants of its own

## Indications for use
The SMR TT Metal Back Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system. The SMR Anatomic Shoulder System is indicated for patients suffering from disability due to: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * Inflammatory degenerative joint disease such as rheumatoid arthritis; * Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; * Revision of a failed primary implant; * Cuff tear arthropathy (CTA Heads); When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid is intended for use with bone cement and should be used without bone screws. The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabling shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K161120
Methodology: https://510kreport.com/methodology