# K112772: Ortholoc (TM) Bone Screws

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 7, 2011 after 14 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: 2 generations back to K082320 (2008). 3 ancestors in all.
68 later devices descend from it; 4 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.

## Most influential descendants
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (2017), 12 descendants of its own
- K120802: Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws (2012), 11 descendants of its own
- K151235: Medline Foot Plates and Screws (2015), 10 descendants of its own

## Indications for use
ORTHOLOC Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K112772
Methodology: https://510kreport.com/methodology