# K931665: 6.5 MM Cancellous Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Feb 17, 1994 after 318 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K190057: DJO Acetabular System (2019), 2 descendants of its own
- K160895: Initia Total Hip System & BIOCERAM AZUL (R) HEAD (2016), 2 descendants of its own
- K251833: EMPOWR Acetabular® Liner Extension (2025), 0 descendants of its own
- K242045: Initia T3 Acetabular Hemispherical Shell System (2025), 0 descendants of its own
- K243444: Bioceram Azul® Head (2024), 0 descendants of its own

## Recalls of this device
- Sep 28, 2012 · Class II · Z-0139-2013: A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there w
- Jul 16, 2012 · Class II · Z-2146-2012: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimen

Source page: https://510kreport.com/device/K931665
Methodology: https://510kreport.com/methodology