# K083607: Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Mar 4, 2009 after 89 days
- Product code: HWC (Screw, Fixation, Bone)
- 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093912: Arthrex Tibial Graftbolt (2010), 3 descendants of its own
- K103060: Arthrex Tibial Graftbolt (2011), 2 descendants of its own
- K103145: Hammerloc TM Tibial Fixation Device (2011), 1 descendant of its own
- K253130: Dione PEEK Screw System (2026), 0 descendants of its own
- K193092: TunneLoc Tibial Fixation Device (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K083607
Methodology: https://510kreport.com/methodology