# K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 11, 2022 after 93 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 17 generations back to K911686 (1991). 121 ancestors in all.
No later device cites it as a predicate yet.
1 of 122 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142413: TITAN Modular Total Shoulder System, Ascension Orthopedics (2014) Summary page 8.
- K100448: Ascension Modular Total Shoulder System, Ascension Orthopedics, Inc. (2010) Summary page 8.
- K112438: Titan Modular Total Shoulder System, Ascension Orthopedic (2012) Summary page 8.
- K152047: INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid, Ascension Orthopedics (2015) Summary page 8.
- K161189: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2016) Summary page 8.
- K173717: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2018) Summary page 8.
- K181999: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2018) Summary page 8.
- K190588: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2019) Summary page 8.
- K062861: Ascension Humeral Resurfacing Arthroplasty System, Ascension Orthopedics, Inc. (2006) Summary page 8.
- K032686: Ascension Modular Radial Head, Ascension Orthopedics, Inc. (2003) Summary page 8.
- K032806: Katalyst Radial Head Implant, Kinetikos Medical, Inc. (2004) Summary page 8.

## Indications for use
The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: * Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. * Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. * Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). Shoulder Hemiarthroplasty is also indicated for: * Ununited humeral head fractures. * Avascular necrosis of the humeral head. * Rotator cuff arthropathy. * Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only. The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. 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 Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use. The Ascension HRA System is intended for resurfacing of the humeral head due to: - Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis) - Mild or moderate humeral head deformity and/or limited motion - Post-traumatic arthritis - Malunions of the humeral head - Acute fractures of the humeral head - Patients with an intact or reparable rotator cuff Contraindications: - Infection, sepsis, and osteomyelitis - Osteoporosis - Metabolic disorders which may impair bone formation - Osteomalacia - Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram - Revision procedures where other devices or treatments have failed The Ascension Modular Radial Head is intended for: * Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnarjoint with: - joint destruction or subluxation visible on x-ray - resistance to conservative treatment * Primary replacement after fracture of the radial head * Symptomatic sequelae after radial head resection * Revision following failed radial head arthroplasty The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

Source page: https://510kreport.com/device/K213827
Methodology: https://510kreport.com/methodology