# K060694: Modular Hybrid Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Dec 11, 2006 after 271 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800494 (1980). 26 ancestors in all.
57 later devices descend from it; 6 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.
- K043061: The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-XX-XX, Zimmer Trabecular (2004) Summary page 1.
- K031449: Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Implex Corp. (2003) Summary page 1.
- K022377: The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306, Implex Corp. (2002) Summary page 1.
- K052472: Depuy Global Shoulder Crosslink Glenoid, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 1.

## Most influential descendants
- K093430: Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd. (2010), 24 descendants of its own
- K091196: GRS Glenoid Resurfacing System (2009), 23 descendants of its own
- K103419: Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM (2010), 22 descendants of its own
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right (2011), 21 descendants of its own
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right (2012), 20 descendants of its own

## Recalls of this device
- Apr 26, 2017 · Class II · Z-2216-2017: Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were
- Feb 17, 2017 · Class II · Z-1859-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- Mar 13, 2008 · Not classified · Z-1658-2008: The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to i
- Dec 6, 12 · Class II · Z-0660-2013: Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in de

## 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 The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Source page: https://510kreport.com/device/K060694
Methodology: https://510kreport.com/methodology