# K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 23, 2008 after 20 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.
215 later devices descend from it; 10 cite it directly.
1 of 216 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 4.5 mm Cannulated Screws: named in the summary without a submission number
- (no number) Synthes 6.5 mm Cannulated Screws: named in the summary without a submission number
- (no number) OsteoMed's Headless Cannulated Screw System: named in the summary without a submission number

## Most influential descendants
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.

Source page: https://510kreport.com/device/K080943
Methodology: https://510kreport.com/methodology