# K133606: N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Apr 1, 2014 after 127 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
Longest line of descent: 9 generations back to K904436 (1990). 63 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 1.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 1.
- K052607: Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws, Arthrex, Inc. (2005) Summary page 2.
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K153186: Adjustable Fixation Device (2016), 1 descendant of its own
- K222971: ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device (2023), 0 descendants of its own

## Indications for use
The N8TIVE™ ACL Anatomic Reconstruction System is indicated for use in the fixation of soft tissue grafts to bone during anterior cruciate ligament reconstruction surgeries of the knee.

Source page: https://510kreport.com/device/K133606
Methodology: https://510kreport.com/methodology