# K193038: Comprehensive Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 28, 2020 after 363 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K800494 (1980). 25 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 4.

## Most influential descendants
- K213856: Identity Shoulder System (2022), 4 descendants of its own
- K240876: Identity Shoulder System (2024), 1 descendant of its own
- K214001: Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (2023), 1 descendant of its own
- K252404: Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (2026), 0 descendants of its own
- K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (2026), 0 descendants of its own

## Recalls of this device
- Mar 3, 2025 · Class II · Z-1403-2025: Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically sig

## Indications for use
1 Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4, Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision in some medical conditions (e. g0 revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure Humeral components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive Hurneral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem. The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System. The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Source page: https://510kreport.com/device/K193038
Methodology: https://510kreport.com/methodology