# K010690: Synthes Titanium Multi-Vector Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 18, 2001 after 71 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Recalls of this device
- May 31, 2013 · Class II · Z-1745-2013: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints t
- Jan 11, 2013 · Class II · Z-0903-2013: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
- Jan 11, 2013 · Class II · Z-0904-2013: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
- Jan 11, 2013 · Class II · Z-0905-2013: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Source page: https://510kreport.com/device/K010690
Methodology: https://510kreport.com/methodology