# K101175: KFX Appianfx Peek Femoral Implant with Inserter

- Pathway: 510(k) (Special)
- Applicant: Kfx Medical
- Decided: May 20, 2010 after 23 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle: named in the summary without a submission number

## Indications for use
The K~x APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (AOL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

Source page: https://510kreport.com/device/K101175
Methodology: https://510kreport.com/methodology