# K980364: Howmedica and Howmedica Leibinger Bone Screw Washers

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Apr 29, 1998 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- 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.
82 later devices descend from it; 1 cites it directly.
0 of 83 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) Howmedica’s Large Cancellous Washer: named in the summary without a submission number
- (no number) Vitallium Washer: named in the summary without a submission number
- (no number) ICS Mini and Small Fregment Set Washer: named in the summary without a submission number
- (no number) Synthes® Mini Fragment Implant Set Washer: named in the summary without a submission number
- (no number) Schuhli Washer: named in the summary without a submission number

## Most influential descendants
- K062498: Profyle System (2006), 81 descendants of its own
- K073527: Variax Elbow System (2008), 61 descendants of its own
- K101056: Variax Elbow System (2010), 58 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K132502: Variax 2 System (2013), 21 descendants of its own

## Indications for use
The washers are intended to be used to provide additional surface arez contact between the screw head and bone surface, when used in combination with bone screws for small bone reconstruction of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.

Source page: https://510kreport.com/device/K980364
Methodology: https://510kreport.com/methodology