# K121713: PMT Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Providence Medical Technology, Inc.
- Decided: Sep 27, 2012 after 108 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K082320 (2008). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K112772: Ortholoc (TM) Bone Screws, Wrightmedicaltechnologyinc (2011) Summary page 1.

## Most influential descendants
- K170698: ALLY (TM) Bone Screws (2017), 0 descendants of its own

## Recalls of this device
- Mar 29, 2019 · Class II · Z-2428-2020: There may be dimensional manufacturing error that represents a potential safety risk to patients.

## Indications for use
PMT 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/K121713
Methodology: https://510kreport.com/methodology