# K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jul 27, 2005 after 133 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K915818 (1992). 18 ancestors in all.
92 later devices descend from it; 8 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991964: Eis Threaded Screw Fracture Fixation, Groupe Lepine (1999) Summary page 2.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 2.
- K021626: Hallu Plates, New Deal, S.A. (2002) Summary page 2.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 2.
- K991873: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 2.
- K021321: Wrist Fusion Plate, Acu Med, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K961941: Liquichek Immunoassay Plus Control Catalog NO. 360,361,362,363, Bio-Rad (1996). Our reading of the summary gave K961941, FDA’s number for Liquichek Immunoassay Plus Control Catalog NO.… (Bio-Rad). Its FDA name has none of the distinctive words the summary uses for the device it names, “Howmedica Profyle Hand & Small Fragment System”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K092670: Biodrive Micro Screw System (2009), 68 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own

## Indications for use
The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot. The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.

Source page: https://510kreport.com/device/K050681
Methodology: https://510kreport.com/methodology