# K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

- Pathway: 510(k) (Traditional)
- Applicant: Memometal Technologies
- Decided: May 19, 2010 after 156 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: 4 generations back to K792670 (1980). 11 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960692: Subtalar Mba System, Kinetikos Medical, Inc. (1996) Summary page 1.
- K031155: Osteomed Subtalar Implant System, Osteomed LP (2003) Summary page 1.
- K032902: Subtalar Arthrorisis Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.
- K041289: Talus of Vilex (Tov), Vilex, Inc. (2004) Summary page 1.
- K080280: Sub-Talar Lok, Model 7-11 MM, Instratek, Inc. (2008) Summary page 1.
- K792670: Smith Subtalar Peg, Dow Corning Wright (1980) Summary page 1.
- K033046: Subtalar Peg Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.
- K051611: Mbaresorb Implant, Kinetikos Medical, Inc. (2005) Summary page 1.
- K071456: Arthrex Prostop Plus Arthroereisis Subtalar Implant, Arthrex, Inc. (2008) Summary page 1.

## Most influential descendants
- K103183: Trilliant Surgical Subtalar Implant (2011), 4 descendants of its own
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own
- K122738: Gaitway Implant System, Surgical Instrument Set (2012), 2 descendants of its own
- K170688: PIT’Stop® implant (2017), 1 descendant of its own

## Indications for use
The Memometal - Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela. The SubFix Arthroereisis Implants are intended for single use only.

Source page: https://510kreport.com/device/K093820
Methodology: https://510kreport.com/methodology