# K110445: Flexfusion (TM) Fixation Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, LLC
- Decided: Mar 17, 2011 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960385 (1996). 7 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 1.
- K990804: Stayfuse, Pioneer Surgical Technology (1999) Summary page 1.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 1.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 1.

## Most influential descendants
- K122031: Nextra TI Hammertoe Correction System (2012), 9 descendants of its own
- K130859: Hammertoe Correction System (2013), 4 descendants of its own
- K200840: DuoHex CH Cannulated Hammertoe System (2020), 3 descendants of its own
- K133515: Peek Fusion Implant (2014), 2 descendants of its own
- K213530: Nextra CH Cannulated Hammertoe System (2021), 1 descendant of its own

## Recalls of this device
- Feb 10, 2022 · Class II · Z-0912-2022: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Feb 10, 2022 · Class II · Z-0910-2022: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Feb 10, 2022 · Class II · Z-0911-2022: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Feb 10, 2022 · Class II · Z-0913-2022: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Feb 10, 2022 · Class II · Z-0914-2022: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Feb 12, 2020 · Class II · Z-1458-2020: Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant

## Indications for use
The Nextremity Solutions FiexFusionTM Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Source page: https://510kreport.com/device/K110445
Methodology: https://510kreport.com/methodology