# K140216: Orthopedic Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Impact Medical, LLC
- Decided: May 1, 2014 after 93 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K761228 (1976). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110086: Ifs Profile Plates, Screws, and Washers, Internal Fixation Systems, Inc. (2011) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K071035: Ifs Bone Fixation Devices, Internal Fixation Systems, Inc. (2007) Summary page 1.
- K061620: Ifs Cannulated Bone Screw, Internal Fixation Systems, Inc. (2006) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 1.

## Indications for use
The Impact Medical, ZIG screws, plates, k-wires and are single use, non-sterile and are indicated for use in: fixation and stabilization of fractures in small and long bones: including at a minimum: the tibia .fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones, calcaneus and for fixation of fractures in the proximal femur and trochanteric, pertrochanteric , intertrochanter ic, and basilar neck fractures Kirschner (K) wires are used in support of fracture fixation, for osteotomies in the presence of adequate immobilization and implant guide wires

Source page: https://510kreport.com/device/K140216
Methodology: https://510kreport.com/methodology