# K123890: Acumed Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Mar 18, 2013 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962823 (1996). 53 ancestors in all.
36 later devices descend from it; 6 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K111316: Aap Cannulated Screws, Aap Implantate AG (2011) Summary page 1.
- K983165: Osteo 4.0MM Cannulated Screw System, Osteonics Corp. (1998) Summary page 1.
- K120493: Mini Cannulated Headed and Headless Screw Set, Instratek, Inc. (2012) Summary page 1.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 1.

## Most influential descendants
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K203011: Monster Screw System (2020), 6 descendants of its own

## Recalls of this device
- Mar 9, 2022 · Class II · Z-0958-2022: Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrog
- Mar 9, 2022 · Class II · Z-0959-2022: Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrog

## Indications for use
The Acumed Cannulated Screw System consists of screws, washers, and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device, which may include the following: Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures; Fractures of the wrist, ankle, elbow, and shoulder; Condylar fractures; Epiphyseal and metaphyseal fractures in children; Osteochrondritis dissecans; Ostero-Chondral Fractures; Ligament avulsion injuries; Ligament fixation; Other small fragment, cancellous bone fractures; Small joint fusion; Areas where accurate screw placement is vital; Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures; Subtalar arthrodesis; Ankle arthrodesis; Fractures of small joints, such as: Ankde fractures, Navicular fractures; Fractures of the fibula, malleolus, and calcaneus; Distal tibia and pilon fractures; Acetabular fractures; Other fractures of the pelvic ring; Sacroiliac joint disruptions; Fractures of the femoral head and neck; Supracondylar femoral fractures; Slipped capital femoral epiphyses; An adjunct to DHS in basilar neck fractures; Pediatric femoral neck fractures; Intercondylar femur fractures; Intracapsular fractures of th6 hip; Fractures of the distal femur and proximal tibia; Paellar fractures; Tibial plateau fractures; Small fragments of the hand and wrist; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Scaphoid fracture and other fractures of the hand; Phalangeal and interphalangeal fractures; Fractures of the ulna and radius; Radial head fractures; Fractures of the olecranon and distal humerus; Humeral head fractures; Ligament fixation at the proximal humerus; and Glenoid fractures. Washers may be used with the screws in certain applications.

Source page: https://510kreport.com/device/K123890
Methodology: https://510kreport.com/methodology