# K062845: Modular Replacement Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 13, 2006 after 82 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Howmedica Modular Proximal Humerus Replacement System: named in the summary without a submission number
- (no number) Osteonics® Total Elbow System: named in the summary without a submission number

## Indications for use
The Modular Replacement Elbow System is intended for use in Oncology patients requiring extensive reconstruction of the distal humerus, including the elbow joint and total humeral replacement, necessitated by extensive bone loss due to tumor resection. These prostheses are intended for use with bone cement as a means of intramedullary fixation. The Modular Replacement Elbow System is also intended for use in patients requiring extensive reconstruction of the distal humerus necessitated by trauma, failed previous prosthesis, distal humeral fracture and/or dislocation, and disabling joint disease of the elbow resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.

Source page: https://510kreport.com/device/K062845
Methodology: https://510kreport.com/methodology