# K112794: Eos Small Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: May 10, 2012 after 227 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915818 (1992). 38 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093676: Omnitech Large, Trimed Compression Screw, TriMed, Inc. (2010) Summary page 2.
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. (2005) Summary page 2.
- K991477: Spin Snap-Off Screw, New Deal, S.A. (1999) Summary page 2.
- K021626: Hallu Plates, New Deal, S.A. (2002) Summary page 2.
- K011716: The Uni-Clip Staple, New Deal, S.A. (2001)
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 2.
- K070033: Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10, Memometal Technologies (2007) Summary page 2.

## Most influential descendants
- K153395: OS2-C Compression Staple (2016), 7 descendants of its own
- K163440: Stealth Staple System (2017), 3 descendants of its own
- K212594: OSSIOfiber® Staple (2022), 2 descendants of its own
- K233302: OSSIOfiber® Compression Staple (2023), 1 descendant of its own
- K220181: StealthFix Intraosseous Fixation System (2022), 1 descendant of its own

## Recalls of this device
- Apr 13, 2018 · Class II · Z-2265-2018: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilizat
- Apr 13, 2018 · Class II · Z-2264-2018: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilizat
- Apr 13, 2018 · Class II · Z-2263-2018: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilizat
- Apr 13, 2018 · Class II · Z-2262-2018: During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilizat

## Indications for use
The components of the TriMed EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the body: Large Cannulated Compression Screws - bones in the foot Cannulated Compression Screws - small bones in the hand and foot Snap-Off Screws - small bones in the foot Bone Plates - first metatarso-phalangeal joint Staples & Pins - small bones in the hand and foot

Source page: https://510kreport.com/device/K112794
Methodology: https://510kreport.com/methodology