# K221758: SMR Stemless Anatomic

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Mar 17, 2023 after 274 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- 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: 8 generations back to K911686 (1991). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183194: Arthrex Eclipse Shoulder Prosthesis System, Arthrex, Inc. (2019) Summary page 4.

## Indications for use
The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to: * non-inflammatory degenerative joint disease including osteoarthritis; * revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant); + glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only). The SMR Stemless Anatomic is intended for uncemented use.

Source page: https://510kreport.com/device/K221758
Methodology: https://510kreport.com/methodology