# K110086: Ifs Profile Plates, Screws, and Washers

- Pathway: 510(k) (Traditional)
- Applicant: Internal Fixation Systems, Inc.
- Decided: Sep 9, 2011 after 240 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: 6 generations back to K000684 (2000). 30 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 1.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 1.
- K092493: GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System, Gpc Medical, Ltd. (2010) Summary page 1.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 1.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 1.
- K071264: Synthes (Usa) 2.4/2.7 MM Locking Foot Module, Synthes (Usa) (2007)
- K072083: Small Fragment Locking Plating System, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008)
- K082527: Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws, Zimmer, Inc. (2008) Summary page 1.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K130614: Bone Fragment and Fixation Plates, Screws and Washers (2014), 2 descendants of its own
- K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers (2025), 1 descendant of its own
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own
- K143721: PRCT2 (2015), 0 descendants of its own
- K140216: Orthopedic Fixation Systems (2014), 0 descendants of its own

## Indications for use
IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.

Source page: https://510kreport.com/device/K110086
Methodology: https://510kreport.com/methodology