# K212435: Comprehensive Humeral Fracture Positioning Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 10, 2021 after 128 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: 6 generations back to K800494 (1980). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193038: Comprehensive Shoulder System, Biomet Manufacturing Corp (2020) Summary page 4.
- K033506: Comprehensive Humeral Fracture Positioning Sleeve, Biomet, Inc. (2004) Summary page 4.

## Indications for use
INDICATIONS 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional defonnity. 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, including cuffarthropathy, where other methods oftreatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications. 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 Humeral 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/K212435
Methodology: https://510kreport.com/methodology