# K952272: TI. Alloy 2.0 MM Cortex Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 31, 1995 after 77 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.
194 later devices descend from it; 3 cite it directly.
1 of 195 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 2.0 mm Cortex Screw: named in the summary without a submission number

## Most influential descendants
- K112885: Zimmer Plates and Screws System Screws Only (2011), 135 descendants of its own
- K962233: Twist-Off Screw (1996), 92 descendants of its own
- K070039: Memometal Fixos Screws (2007), 84 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own

## Indications for use
Synthes Ti. Alloy 2.0 mm Cortex Screw is intended for fixation of fractures of the fingers.

Source page: https://510kreport.com/device/K952272
Methodology: https://510kreport.com/methodology