# K032507: Interlok Bio-Modular Humeral Stems

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Sep 5, 2003 after 22 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992119 (1999). 1 ancestor in all.
123 later devices descend from it; 2 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K071147: Nexa Orthopedics Total Shoulder System (2007), 120 descendants of its own
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K113413: Ascend Shoulder System (2012), 105 descendants of its own
- K120794: Ascend Shoulder System (2012), 98 descendants of its own

## Indications for use
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Revision where other devices or treatments have failed Correction of functional deformity Fractures of the proximal humerus, where other methods of treatment are deemed inadequate Difficult clinical management problems, including cuff arthropathy, where other methods may not be suitable or may be inadequate Non-coated (Interlok®) devices are indicated for cemented application only.

Source page: https://510kreport.com/device/K032507
Methodology: https://510kreport.com/methodology