# K033506: Comprehensive Humeral Fracture Positioning Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 2, 2004 after 89 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: 3 generations back to K872454 (1987). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032507: Interlok Bio-Modular Humeral Stems, Biomet, Inc. (2003) Summary page 1.
- K023063: Comprehensive Humeral Fracture System, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K212435: Comprehensive Humeral Fracture Positioning Sleeves (2021), 0 descendants of its own

## Indications for use
The Comprehensive Humeral Fracture Positioning Sleeve is indicated for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthopathy, where other methods of treatment may not be suitable or may be inadequate. For Cemented Use Only

Source page: https://510kreport.com/device/K033506
Methodology: https://510kreport.com/methodology