# K233712: PRIMA Humeral System; PRIMA TT Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jan 11, 2024 after 52 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K911686 (1991). 258 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 260 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222427: PRIMA TT Glenoid, Lima Corporate S.P.A. (2022) Summary page 6.
- K212800: PRIMA Humeral System and SMR Glenosphere Ø42, Lima Corporate S.P.A. (2022) Summary page 6.
- 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 8.

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

## Indications for use
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 Short Stem and PRIMA Short Stem Plus are 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 Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the 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 Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

Source page: https://510kreport.com/device/K233712
Methodology: https://510kreport.com/methodology