# K023063: Comprehensive Humeral Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Dec 13, 2002 after 88 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872454 (1987). 11 ancestors in all.
146 later devices descend from it; 5 cite it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K961571: Cocr BI-Angular Humeral Component, Biomet, Inc. (1996) Summary page 1.
- K961260: Kirschner Sholders with Titanium Plasma Spray, Biomet, Inc. (1997) Summary page 1.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K060692: Comprehensive Primary Shoulder Stems (2006), 138 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
- K120794: Ascend Shoulder System (2012), 98 descendants of its own
- K121493: Ascend Shoulder System (2012), 97 descendants of its own

## Recalls of this device
- Jun 5, 2017 · Class II · Z-0298-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Aug 3, 2011 · Not classified · Z-3289-2011: Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were di

## Indications for use
The Comprehensive Humeral Fracture Stems are 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 arthropathy, where other methods of treatment may not be suitable or may be inadequate. The InterlokB finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBondThfcoated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.

Source page: https://510kreport.com/device/K023063
Methodology: https://510kreport.com/methodology