# K193214: WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 10, 2020 after 355 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 6 generations back to K922322 (1992). 41 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981967: Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System, Channel Ligament Clamp, Heckman Scre, Arthrotek/Biomet, Inc. (1998) Summary page 6.
- K122437: NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers, Biomet Sports Medicine (2013) Summary page 6.
- K140891: Biomet Cannulated Screw System, Biomet, Inc. (2014) Summary page 6.
- K143188: 3.Omm Biomet Cannulated Screw System, Biomet Manufacturing Corp (2014) Summary page 6.
- K190035: Biomet Headless Compression and Twist-Off Screws, Biomet, Inc. (2019) Summary page 6.

## Most influential descendants
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
Soft tissue fixation to bone, specifically during ligament reconstructive procedures. 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. The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

Source page: https://510kreport.com/device/K193214
Methodology: https://510kreport.com/methodology