# K042664: LPS Upper Extremity

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Dec 8, 2004 after 71 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925613 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 2.
- K020045: 3-Piece Proximal Humeral Replacement System, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System, Biomet, Inc. (2003) Summary page 2.
- K992656: Depuy Total Elbow System, DePuy Orthopaedics, Inc. (1999) Summary page 2.

## Indications for use
The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include: * Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus; * Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate; * Patient conditions of noninflammatory degenerativejoint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus; * Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis; * Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate; * Persistent humeral fracture non-union; * Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment; * Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus. * Severe trauma requiring extensive resection and replacement The LPS Upper Extremity components are for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K042664
Methodology: https://510kreport.com/methodology