# K221333: Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Dec 29, 2022 after 234 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962823 (1996). 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)
- K930834: Acutract, Acu Med, Inc. (1993) Summary page 4.
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 4.
- K110658: Aptus Cannulated Compression Screws, Medartis AG (2011) Summary page 4.
- K123890: Acumed Cannulated Screw System, Acumed, LLC (2013) Summary page 4.
- K163303: OsteoMed ExtremiFix Mid and Large Screw System, Osteomed, LLC (2017) Summary page 4.
- K202680: OsteoMed ExtremiFix Mini & Small Cannulated Screw System, Osteomed, LLC (2020) Summary page 4.

## Recalls of this device
- Nov 29, 2022 · Class II · Z-0767-2023: Distribution without Pre-Market Clearance
- Nov 29, 2022 · Class II · Z-0769-2023: Distribution without Pre-Market Clearance
- Nov 29, 2022 · Class II · Z-0768-2023: Distribution without Pre-Market Clearance
- Nov 29, 2022 · Class II · Z-0770-2023: Distribution without Pre-Market Clearance

## Indications for use
Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation. Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous. The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

Source page: https://510kreport.com/device/K221333
Methodology: https://510kreport.com/methodology