# K934469: Arthrotek Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 23, 1994 after 166 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (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
- K193451: Titanium Interference Screws (2020), 0 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0630-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Jan 3, 2013 · Class II · Z-0753-2013: Thru hole at the tip of the screw is undersized.

Source page: https://510kreport.com/device/K934469
Methodology: https://510kreport.com/methodology