# K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 1, 1996 after 74 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.
836 later devices descend from it; 20 cite it directly.
1 of 837 devices in its family (counting itself) has 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) Synthes 2.7 mm Cannulated Screw and Threaded Washer: named in the summary without a submission number

## Most influential descendants
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K993762: I.CO.S Screw (2000), 338 descendants of its own
- K024233: Kompressor Screw System (2003), 299 descendants of its own
- K040356: Kompressor Screw System (2004), 255 descendants of its own
- K060071: Nexa Compression Screw (2006), 251 descendants of its own

## Indications for use
Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.

Source page: https://510kreport.com/device/K962823
Methodology: https://510kreport.com/methodology