# K162171: S4 Screw System™

- Pathway: 510(k) (Traditional)
- Applicant: Subchondral Solutions
- Decided: Sep 7, 2017 after 400 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: 8 generations back to K962823 (1996). 79 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123890: Acumed Cannulated Screw System, Acumed, LLC (2013) Summary page 4.
- K132217: Arthrex Compression FT Screws, Arthrex, Inc. (2013) Summary page 4.

## Most influential descendants
- K191995: S4 Screw System (2020), 2 descendants of its own
- K231649: Intraosseous Fusion Device System (2023), 0 descendants of its own
- K220901: S-Core Implant System (2022), 0 descendants of its own

## Indications for use
The S4 Screw System™ is indicated for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments, appropriate for the size of the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar rim, navicular); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.

Source page: https://510kreport.com/device/K162171
Methodology: https://510kreport.com/methodology