# K143188: 3.Omm Biomet Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Dec 30, 2014 after 55 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922322 (1992). 29 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140891: Biomet Cannulated Screw System, Biomet, Inc. (2014) Summary page 4.
- K082874: Biodrive Cannulated Screw System, Biomet Trauma (2009) Summary page 4.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 4.
- K062352: FRS Screw, DePuy Orthopaedics, Inc. (2006) Summary page 4.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.

## Most influential descendants
- K193214: WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws (2020), 3 descendants of its own
- K180808: Omni Foot Plating System (2018), 3 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K212297: Omni Foot and Ankle Plating System (2021), 1 descendant of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0616-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## Indications for use
1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow. 2. Arthrodesis of the foot, wrist and elbow. 3. Small and long bone osteotomies. 4. Fracture fixation of small bones, small bone fragments and long bones.

Source page: https://510kreport.com/device/K143188
Methodology: https://510kreport.com/methodology