# K100721: Locking Bone Screw Model HCQ04, HCZ04

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Orthmar Medical Instrument Co., Ltd.
- Decided: Nov 23, 2010 after 253 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
Longest line of descent: 6 generations back to K981372 (1998). 14 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081513: Merete 3.0 and 3.5 MM Locking Screws, Merete Medical GmbH (2008) Summary page 2.

## Most influential descendants
- K130340: Locking Bone Plates and Screws (2013), 7 descendants of its own
- K133840: Kangli Locking Plate System (2014), 2 descendants of its own
- K143002: Metallic Locking Bone Plate and Screw System (2015), 1 descendant of its own
- K150009: Baide (2015), 1 descendant of its own
- K131759: Metallic Locking Compression Bone Plates and Screws System (2013), 1 descendant of its own

## Indications for use
Locking Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Source page: https://510kreport.com/device/K100721
Methodology: https://510kreport.com/methodology