# K103243: 2.4MM VA-LCP Intercarpal Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 21, 2011 after 81 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915818 (1992). 13 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990094: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 1.
- K991873: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 1.
- K021321: Wrist Fusion Plate, Acu Med, Inc. (2002) Summary page 1.

## Most influential descendants
- K123562: Flower Small and Medium Bone Implants (2013), 14 descendants of its own
- K131657: Flower Small and Medium Implant Set (2013), 11 descendants of its own
- K152306: MotoBand¿ CP Implant System (2015), 7 descendants of its own
- K160300: MotoBand (TM) CP Implant System (2016), 6 descendants of its own
- K173710: MotoBAND CP Implant System (2018), 4 descendants of its own

## Recalls of this device
- Dec 16, 2019 · Class II · Z-0879-2020: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed
- Dec 16, 2019 · Class II · Z-0882-2020: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed
- Dec 16, 2019 · Class II · Z-0883-2020: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed
- Dec 16, 2019 · Class II · Z-0880-2020: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed
- Dec 16, 2019 · Class II · Z-0881-2020: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed
- Jun 28, 2016 · Class II · Z-2389-2016: It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being 
- Nov 2, 2015 · Class II · Z-0323-2016: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above pa

## Indications for use
The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to: -Osteoarthritis -Rheumatoid arthritis -Post-traumatic or degenerative wrist arthritis -Carpal instability

Source page: https://510kreport.com/device/K103243
Methodology: https://510kreport.com/methodology