# K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medical GmbH & Co. KG
- Decided: Nov 7, 2012 after 194 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 K961522 (1996). 11 ancestors in all.
24 later devices descend from it; 7 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050819: Charlotte Snap-Off Screw, Wrightmedicaltechnologyinc (2005) Summary page 3.
- K091118: Foot and Hand Motion System, Newclip Technics (2009) Summary page 3.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 3.
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 3.
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 3.
- K962705: Mli Modular Staple, Medicinelodge, Inc. (1996) Summary page 3.

## Most influential descendants
- K131061: Restore Bunion Correction System (2013), 15 descendants of its own
- K170214: Additive Orthopaedics Locking Lattice Plate (2017), 8 descendants of its own
- K222645: Treace Medical Concepts (TMC) Implant Fixation System (2022), 6 descendants of its own
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), 5 descendants of its own
- K232387: Treace Medical Concepts (TMC) Compression Implant System (2023), 4 descendants of its own

## Indications for use
The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * Fixation of small bone fragments * Well osteotomy * Mono-cortical fixation * Osteotomies and fractures fixation in the foot and hand The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included: * Fixation of bone fragments or small bone fractures * Fracture management in the foot and hand * Arthrodesis in hand, foot or ankle surgery * Mono or Bi-cortical osteotomies in the foot and hand The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system. The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included: * Fixation of bone fragments or small bones fractures * Fracture management in the foot and hand

Source page: https://510kreport.com/device/K121277
Methodology: https://510kreport.com/methodology