# K212800: PRIMA Humeral System and SMR Glenosphere Ø42

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Feb 25, 2022 after 176 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K911686 (1991). 185 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 188 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190290: AltiVate Reverse Humeral Stem, 48mm, Encore Medical L.P. (2019) Summary page 12.
- K162024: AltiVate Anatomic Shoulder System, Encore Medical L.P. (2016) Summary page 12.
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert, Encore Medical L.P. (2017) Summary page 12.
- K173073: AltiVate Anatomic to Reverse Conversion Module, Encore Medical L.P. (2017) Summary page 12.
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 12.
- K201315: PERFORM Humeral System – Stem, Tornier, Inc. (2020) Summary page 12.
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 8.

## Most influential descendants
- K233712: PRIMA Humeral System; PRIMA TT Glenoid (2024), 1 descendant of its own
- K251184: AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (2025), 0 descendants of its own

## Recalls of this device
- May 19, 2025 · Class II · Z-2025-2025: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
- May 19, 2025 · Class II · Z-2024-2025: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

## Indications for use
PRIMA Humeral System The PRIMA humeral system is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. 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. The PRIMA Stem is intended for use in cementless and cemented applications, at the discretion of the surgeon. The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to: • Non-inflammatory degenerative joint disease (i.e. osteoarthritis), • Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, • Avascular necrosis of the humeral head, • Traumatic/post-traumatic arthritis, • Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains, • Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains, • Cuff tear arthropathy (CTA Heads only). The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e., in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy). Revision surgery with retention of the PRIMA Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA Stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The PRIMA reverse implant is indicated for patients suffering from pain and disability due to: • Rotator cuff tear arthropathy, • Osteoarthritis with rotator cuff tear, • Rheumatoid arthritis with rotator cuff tear, • Massive irreparable rotator cuff tear, • Avascular necrosis of the humeral head, • Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains, • Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains. The PRIMA Humeral System consists of the following single use components: • Anatomic configuration: - stem - adaptor for humeral heads. • Reverse configuration: - stem - reverse tray and - reverse insert. The PRIMA Humeral System is intended to be used with all SMR glenoid implants. SMR Glenosphere Ø42 The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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; in case of SMR Short Stems only if sufficient bone stock remains); • cuff tear arthropathy (CTA Heads only); • glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only). 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 (disabled 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. The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

Source page: https://510kreport.com/device/K212800
Methodology: https://510kreport.com/methodology