# K140891: Biomet Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 3, 2014 after 56 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922322 (1992). 20 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082874: Biodrive Cannulated Screw System, Biomet Trauma (2009) Summary page 2.
- K926047: Ace 8.0MM Cannulated Cancellous Bone Screw, Ace Orthopedic Manufacturing Co. (1993) Summary page 1.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 2.
- K872859: Ace Cancellous Bone Screw, Ace Medical Co. (1987) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K092909: Synthes 7.3 MM Cannulated Slipped Capital Femoral Epiphysis Screws (Scfe), Synthes (Usa) (2010) Summary page 1.

## Most influential descendants
- K143188: 3.Omm Biomet Cannulated Screw System (2014), 8 descendants of its own
- 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
- K213199: Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (2022), 2 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0617-2021: 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.
- Nov 25, 2020 · Class II · Z-0618-2021: 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.
- May 14, 2020 · Class II · Z-2304-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2303-2020: Distributed to the field without having completed design history files or design transfer activities
- Dec 7, 2017 · Class II · Z-1064-2018: One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

## Indications for use
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in: 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. Large Cannulated Screws (5mm and larger in diameter) are intended for use in: 1. Fixation of fractures in long bones and long bone fragments. 2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon). 3. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures. Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in: 1. Slipped capital femoral epiphysis 2. Pediatric femoral neck fractures 3. Tibial plateau fractures 4. SI joint disruptions 5. Intercondylar femur fractures 6. Subtalar arthrodesis 7. Fixation of pelvis and iliosacral joint.

Source page: https://510kreport.com/device/K140891
Methodology: https://510kreport.com/methodology