# K992525: Acumed Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Feb 4, 2000 after 191 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K873073 (1987). 6 ancestors in all.
76 later devices descend from it; 4 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961260: Kirschner Sholders with Titanium Plasma Spray, Biomet, Inc. (1997) Summary page 1.
- K962224: Select Shoulder Concentric Humeral Head Components, Intermedics Orthopedics (1996) Summary page 1.

## Most influential descendants
- K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies, (2011), 38 descendants of its own
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, (2010), 37 descendants of its own
- K111097: Humelock Cemented Shoulder Prosthesis (2011), 34 descendants of its own
- K110847: SMR Shoulder System - Cta Humeral Heads (2011), 34 descendants of its own
- K111212: SMR Shoulder System- Revision Stems (2011), 33 descendants of its own

## Recalls of this device
- May 13, 2008 · Not classified · Z-0447-2009: The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.

## Indications for use
Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.

Source page: https://510kreport.com/device/K992525
Methodology: https://510kreport.com/methodology