# K060156: Straight Plate with Angular Stability & Screw System

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Mar 20, 2006 after 59 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 36 ancestors in all.
27 later devices descend from it; 7 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050852: Claviculaplate with Angular Stablity Bone Plate System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 1.
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 1.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005). Our reading of the summary gave K051916, FDA’s number for Polar Cath Peripheral Dilatation System (Cryo Vascular Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes 4.5mm LCP Straight Reconstruction Plate”.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K051642: FR.O.H. Calcaneus Repair System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K003496: Cannulated Screw System, Pioneer Surgical Technology (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K051098: Periarticular Locking Plates and Screws, Model 2358 Series, Zimmer, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K024853: Synthes (USA) Spherical Washers. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K063166: I.T.S. Pelvic Reconstruction System (2006), 9 descendants of its own
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own
- K161904: GEO Bone Screw System (2017), 4 descendants of its own
- K122538: Acumed Pelvic Bone Plate System (2012), 4 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1598-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
- Jan 23, 2026 · Class II · Z-1599-2026: 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 Intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient. Indications for use include comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may only be used on small bones. The Intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient. For the 4.0mm Cannulated Cancellous Screw indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, Maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supramalleolar fractures and the instability of the talus centering. For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibial plateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal tibia, fixation of the ilio-sacral joint, and fusion of the foot and ankle. For the 7.3mm Cannulated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibial plateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the ilio-sacral joint, and metaphyseal fractures of the distal femur and distal tibia. The system(s) is not intended for spinal use.

Source page: https://510kreport.com/device/K060156
Methodology: https://510kreport.com/methodology