# K221090: Metal Cannulated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Jan 10, 2023 after 272 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: 12 generations back to K962616 (1996). 167 ancestors in all.
No later device cites it as a predicate yet.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 5.
- K143229: Nexis osteosynthesis compressive screws, Novastep (2015) Summary page 5.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 5.
- K182361: Arthrex Compression FT Screws, Arthrex, Inc. (2018) Summary page 5.
- K170382: Arthrex Compression Screws, Arthrex, Inc. (2017) Summary page 5.
- K162353: MICATM Screw System, Wrightmedicaltechnologyinc (2017) Summary page 5.

## Indications for use
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot: 1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. 2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, radius, fibula, and small bones (metacarpals, metatarsals, and phalanges). 3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments. 4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, and the bones of the hand and foot. 5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis. 6)The Headless Cannulated Screw (2.5-4.5mm) /Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint. 7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint. 8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges. 9)The 6.5mm Cannulated Screw are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis. 10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.

Source page: https://510kreport.com/device/K221090
Methodology: https://510kreport.com/methodology