# K122123: 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw 8-10MM X 30 MM Intrafix Peek Tapered

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company
- Decided: Oct 2, 2012 after 76 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: 6 generations back to K971358 (1997). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener, Innovasive Devices, Inc. (1999) Summary page 1.
- K063577: Femoral Intrafix Screw and Sheath, Johnson & Johnson Company (2007) Summary page 1.

## Most influential descendants
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) (2013), 4 descendants of its own
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (2013), 3 descendants of its own
- K171114: HEALIX ADVANCE KNOTLESS Anchor (2017), 2 descendants of its own
- K180101: HEALIX ADVANCE KNOTLESS BR Anchor (2018), 1 descendant of its own
- K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (2024), 0 descendants of its own

## Indications for use
The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K122123
Methodology: https://510kreport.com/methodology