# K030710: Bio-Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 4, 2003 after 90 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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: 3 generations back to K800494 (1980). 14 ancestors in all.
253 later devices descend from it; 20 cite it directly.
1 of 268 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872454: Biomet Modular Shoulder Prosthesis, Biomet, Inc. (1987) Summary page 1.
- K915596: Biomodular Shoulder Humeral Head W/ Ionguard, Biomet, Inc. (1992) Summary page 1.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.
- K992899: Bio-Modular Shoulder Offset Humeral Heads, Biomet, Inc. (1999) Summary page 1.
- K002998: Biomet BI-Polar Shoulder System, Biomet, Inc. (2000) Summary page 1.
- K914695: Global Total Shoulder, Depuy, Inc. (1992) Summary page 1.
- K943300: Depuy Porous Coated Global Shoulder, Depuy, Inc. (1994) Summary page 1.
- K974044: Global Total Shoulder Eccentric Humeral Head, DePuy Orthopaedics, Inc. (1998) Summary page 1.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 1.
- K011047: Global Advantage Humeral Stem with Porocoat, DePuy Orthopaedics, Inc. (2001)

## Most influential descendants
- K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components (2005), 176 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K060692: Comprehensive Primary Shoulder Stems (2006), 138 descendants of its own
- K071147: Nexa Orthopedics Total Shoulder System (2007), 120 descendants of its own

## Recalls of this device
- Nov 1, 2012 · Class II · Z-0474-2013: The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing

## Indications for use
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 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

Source page: https://510kreport.com/device/K030710
Methodology: https://510kreport.com/methodology