# K093868: I.T.S. LRS Locking Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Aug 5, 2010 after 231 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 9 generations back to K962616 (1996). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- K061012: Axsos Plus Locking Plate System, Howmedica Osteonics Corp. (2006) Summary page 1.
- K092015: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2009) Summary page 1.
- K070906: Modificaton to: Zimmer Periarticular Locking Plates and Screws, Zimmer, Inc. (2007) Summary page 1.
- K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 1.

## Most influential descendants
- K260958: I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (2026), 0 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1603-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

## Indications for use
The I.TS. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less mhan or equal to 21 years old) or adult patient. Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K093868
Methodology: https://510kreport.com/methodology