# K955306: Omega+ Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Apr 10, 1996 after 142 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 1 generation back to K850886 (1985). 4 ancestors in all.
15 later devices descend from it; 4 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)
- K850886: Compression Hip Screw System, Pfizer, Inc. (1985) Summary page 1.
- K872223: Modified Omega Compression Hip Screw System, Howmedica Corp. (1987) Summary page 1.
- K922295: Omega Plus Compress Hip Screw System, Modification, Howmedica Corp. (1992) Summary page 1.
- K930156: Mega Plus Super Lag Screw, Pfizer Hospital Products Group, Inc. (1994) Summary page 1.

## Most influential descendants
- K970258: Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures (1997), 8 descendants of its own
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K984331: Odi Ultimate Compression Hip Screw (1999), 3 descendants of its own
- K033286: Odi Talon Long Proximal Femoral Nail System (2004), 2 descendants of its own
- K111352: Talon Distalfix Proximal Femoral Nail (2011), 1 descendant of its own

## Recalls of this device
- Jan 25, 2005 · Not classified · Z-1865-2008: Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.

## Indications for use
The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area).

Source page: https://510kreport.com/device/K955306
Methodology: https://510kreport.com/methodology