# K962194: Mli Soft Tissue Screw & Washer System

- Pathway: 510(k) (Traditional)
- Applicant: Medicinelodge, Inc.
- Decided: Jul 30, 1996 after 53 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Linvatec Concept Soft Tissue Anchoring Implants: named in the summary without a submission number
- (no number) Arthrotek Ligament Screw System: named in the summary without a submission number
- (no number) Mitek Screws and Washers: named in the summary without a submission number

## Most influential descendants
- K981967: Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System, Channel Ligament Clamp, Heckman Scre (1998), 5 descendants of its own
- K122437: NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers (2013), 4 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
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own

## Indications for use
MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

Source page: https://510kreport.com/device/K962194
Methodology: https://510kreport.com/methodology