# K043061: The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-XX-XX

- Pathway: 510(k) (Special)
- Applicant: Zimmer Trabecular
- Decided: Nov 23, 2004 after 18 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022377 (2002). 2 ancestors in all.
58 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022377: The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306, Implex Corp. (2002) Summary page 1.
- K031449: Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Implex Corp. (2003) Summary page 1.

## Most influential descendants
- K060694: Modular Hybrid Glenoid (2006), 57 descendants of its own
- 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

## Indications for use
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.

Source page: https://510kreport.com/device/K043061
Methodology: https://510kreport.com/methodology