# K251184: AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: May 16, 2025 after 30 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: 20 generations back to K911686 (1991). 260 ancestors in all.
No later device cites it as a predicate yet.
1 of 261 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233481: AltiVate Reverse® Glenoid, Encore Medical L.P. (2024) Summary page 9.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 10.
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 10.
- K141006: RSP Humeral Socket Insert, Djo Global (2014) Summary page 10.
- K142139: SMR 40MM Glenosphere, Lima Corporate S.P.A. (2014) Summary page 10.
- 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 10.
- K212800: PRIMA Humeral System and SMR Glenosphere Ø42, Lima Corporate S.P.A. (2022) Summary page 10.
- K220792: SMR Reverse Liner, Lima Corporate S.P.A. (2022) Summary page 10.
- K222427: PRIMA TT Glenoid, Lima Corporate S.P.A. (2022) Summary page 10.
- K233712: PRIMA Humeral System; PRIMA TT Glenoid, Lima Corporate S.P.A. (2024) Summary page 10.

## Indications for use
AltiVate Reverse® Shoulder System: Indications for RSP® Modular Stem: The Reverse® Shoulder Prosthesis (RSP®) Humeral Stem and Socket Shell are indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only. Indications for RSP® Monoblock Stem: The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint: • In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. • In cases of bone defect in proximal humerus. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s). The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or Cementless use (Cementless use not cleared in the EU). Indications for AltiVate Reverse® Humeral Stem and Small Shell Humeral Stem (Primary, Short Stem and Revision) Reverse Total Shoulder Indications: The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: • Severe arthropathy with a grossly deficient rotator cuff; • Previously failed joint replacement with a grossly deficient rotator cuff; • Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; • Bone defect in proximal humerus; • Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; • Inflammatory arthritis including rheumatoid arthritis; • Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use. SMR Shoulder System: 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. The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table. In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented. The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented. 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 Humeral System consists of the following single use components: • Anatomic configuration: - stem - adaptor for humeral heads. • Reverse configuration: - stem - reverse tray - reverse insert. The PRIMA Humeral System is intended to be used with all glenoids implants belonging to the SMR Shoulder System and PRIMA Glenoid System. The PRIMA Humeral System is compatible with the RSP® Glenoid and AltiVate Reverse® Glenoid systems only when a diameter 36 or 40mm PRIMA Reverse Insert LimaVit are used. Instructions for use of the Enovis Reverse Shoulder System should be consulted prior to use. 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/K251184
Methodology: https://510kreport.com/methodology