# K151701: Tenodesis screw system

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Jan 26, 2016 after 216 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
Longest line of descent: 3 generations back to K943806 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143165: Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw, Zimmer, Inc. (2015) Summary page 5.
- K061211: NCB Plating System, Proximal Tibia Plates, Zimmer GmbH (2006) Summary page 5.
- K083150: G-Force Tenodesis Screw, Wrightmedicaltechnologyinc (2009) Summary page 5.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 5.
- K041274: Resorbable Interference Screw, Arthrotek, Inc. (2004) Summary page 5.

## Indications for use
The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery. The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.

Source page: https://510kreport.com/device/K151701
Methodology: https://510kreport.com/methodology