# K031449: Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Sep 23, 2003 after 139 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022377 (2002). 1 ancestor in all.
60 later devices descend from it; 3 cite it directly.
0 of 62 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.
- (no number) B/F all-poly glenoid components: named in the summary without a submission number

## Most influential descendants
- K043061: The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-XX-XX (2004), 58 descendants of its own
- 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

## Recalls of this device
- Aug 23, 2005 · Not classified · Z-0023-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0024-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0026-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0030-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0027-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0029-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0025-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Aug 23, 2005 · Not classified · Z-0028-06: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.

## 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/K031449
Methodology: https://510kreport.com/methodology