# K092381: Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor, Akrfx Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Ibalance Medical, Inc.
- Decided: Oct 27, 2009 after 83 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K973812 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032187: Anthrex Titanium Opening Wedge Osteotomy System, Arthrex, Inc. (2003) Summary page 1.
- K033303: Wafer System, Spine Wave, Inc. (2004) Summary page 1.
- K011583: Spiked Washer, Synthes (Usa) (2002). Our reading of the summary gave K001583, FDA’s number for Island Biosurgical BNS Kit #3 (Island Biosurgical, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Spiked Washer”.
- K073426: Aperfix Interference Screw 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM, Cayenne Medical, Inc. (2008) Summary page 1.
- K083607: Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM, Cayenne Medical, Inc. (2009) Summary page 1.

## Indications for use
The iBalance AKRFx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening Wedge osteotomies. It is intended to be used with adequate post-operative immobilization.

Source page: https://510kreport.com/device/K092381
Methodology: https://510kreport.com/methodology