# 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

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Jun 16, 2026 after 85 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: 12 generations back to K962616 (1996). 280 ancestors in all.
No later device cites it as a predicate yet.
0 of 281 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 9.
- K033756: Volar Radius Plate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2004) Summary page 9.
- K051412: Humeral Head Plate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 9.
- K051642: FR.O.H. Calcaneus Repair System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 9.
- K052011: Pilonplate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 9.
- K052368: Olecranonplate with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 9.
- K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 9.
- K063166: I.T.S. Pelvic Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 9.
- K063672: Fibula Plate Prolock with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2007) Summary page 9.
- K080184: Distal Humeral Plates with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2008) Summary page 9.
- K093868: I.T.S. LRS Locking Reconstruction System, I.T.S. Implantat-Technologie-Systeme GmbH (2010) Summary page 9.
- K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking, I.T.S. GmbH (2013) Summary page 9.
- K131722: I.T.S. Extremity Fixation Systems, I.T.S. GmbH (2013) Summary page 9.
- K142418: I.T.S. Hand Locking Plates System - HLS, I.T.S. GmbH (2014) Summary page 9.
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix), I.T.S. GmbH (2022) Summary page 9.
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail, I.T.S. GmbH (2014) Summary page 9.

## Indications for use
The I.T.S. Clavicle Plates with Angular Stability is a titanium implant fracture fixation system for repairing fractures located from the middle third to the distal third of the clavicle. Indications for Use include metaphyseal and diaphyseal fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Other indications include corrective osteotomy and open and closed fractures. All fractures of the clavicle in metaphyseal and diaphyseal areas. Hygienisaton of pseudo-arthroses with or without spongiosal graft. Corrective osteotomy. Open and closed fractures. The I.T.S. Volar Radius Plates with Angular Stability is a titanium implant fracture fixation system for distal radius fractures of the wrist. Indications for Use include comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures. Complex intra-articular fractures of the distal radius. Complex extra-articular fractures of the distal radius. Osteotomies of the distal radius. The I.T.S. Humeral Head Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. All stable and unstable humerus fractures with or without shaft involvement. Fractures of the greater or lesser tuberosities. Repair of the greater tuberosity following prior fixation failure or tuberosity “escape”. Delayed or nonunion of the proximal humerus. Fixation following osteotomy of proximal humeral malunion. Displaced two, three and four part fracture of the proximal humerus. Displaced anterior and posterior fractures of the proximal humerus and greater tuberosity. Nonunion of two, three and four part fractures of the proximal humerus. Nonunion of anterior and posterior fracture-dislocations of the proximal humerus and greater tuberosity. Dislocated, unstable 2, 3 and 4-segment fractures of the humeral head. Valgus-impacted 4-segment fractures of the humeral head. Non-union of the humeral head. The I.T.S. F.R.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot. Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tongue type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients. Complex Fractures of the Calcaneus. All intra-articular fractures with relevant joint distortion and comminution zone in which a semi-operative procedure (screws, drill wires) does not raise expectations of exact repositioning. Fractures of the sustentaculum tali. The I.T.S. Pilon Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg. Indications for Use include fixation of complex intra- and extraarticular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia. Fractures of the tibial pilon of AO classification A3, especially groups C2 and C3. The I.T.S. Olecranon Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow. Indications for Use include fixation of complex intra- and extraarticular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon). All fractures of the olecranon. The intended use of the I.T.S. Straight Plates 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 communted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, non-unions, and mal-unions, 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 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 patellas and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supramalleolar fractures and the instabilty of the talus centering. For the 6.5mm Cannulated Canncellous Screw, indications for use are for fractures of the femoral neck, tiblaplateau, of the sacrum and the articular cavity of the hip joint and the metaphyseal fractures of the distal femur and distal tbia, fixation of the ilio-sacal 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, tiblaplateau, 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 intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the pelvic ring area of the pelvis of an adult or pediatric patient. The indications for use of the I.T.S. PRS Sacral Rod System include fixation of fractures of the posterior pelvis, fixation of fractures of the posterior iliac spine, fixation of fractures of the posterior inferior iliac spine, dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries, fixation of sacral fractures, and fracture dislocations of the sacro-iliac joint. The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula. Indications for Use include metaphyseal and diaphyseal fracture fixation of acute fractures, mal-unions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures. Dislocated ankle-fractures group B+C according to Weber (with or without comminuted zones). The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient. Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus. Supra- & diacondylar upper-arm fractures. The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur of all pediatric patients (less than or equal to 21 years old) or adult patient. Indications for Use include distal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur. The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the proximal lateral tibia of all pediatric patients (less than or equal to 21 years old) or adult patient. Indications for Use include proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the proximal tibia. The Indications for Use of the I.T.S. GmbH - Distal Ulna Locking (DUL) Plate Systems is to stabilize fractures in the long bone of the distal ulna of an adult patient. Fractures of the ulnar head. Multifragmentary fracture of the ulnar head. Subcapital fractures of the ulnar head. Metaphyseal comminuted fractures of the distal ulna. Combined ulnar head and ulnar shaft fractures. The Indications for Use of the I.T.S. GmbH - Ulna Osteotomy Locking (UOL) Plate Systems is to stabilize osteotomies in the long bone of the mid-ulna of an adult patient. Impaction syndrome of the ulnar wrist. Symptomatic, post-traumatic ulnar malposition in the distal radio-ulnar joint (DRUJ). Degenrerative ulnar wrist. Correction of the ulnar positive relative to the unaffected other side up to a maximum of 6mm in one step or 13mm in two steps. The I.T.S. FLS Foot Locking Plate System is indication for use in internal fixation, reconstruction or athrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procederes may included but are not limited to replantation, lag srew techniques, joint fusions, corrective osteotomies, and treatment of fracture. Metatarsal fractures. TMT I-V Arthrodesis, MTP I-V Arthrodesis, TN, CC Arthrodesis, Corrective Osteotomies. The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicorlical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint: fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions. And for sizes 4.3mmn or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur and tibia. The size of the chosen compression screw should be adapted to the specific indication. The I.T.S. HOL - Hallux Osteotomy Locking Plate System is Indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 25°. Intramedullary, self locking plate for distal metatarsal osteotomies. Hallux Valgus osteotomies up to a corrective angle of 25°. The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil- Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. For treatment of fractures, corrective osteotomies, arthrodesis and degenerative transformations of small bones. The I.T.S. Hand Locking Plate System -HLS is indicated for use in fracture fixation of: The phalanges, The metacarpal bones, The carpal bones, For arthrodesis, For corrective osteotomies and For subcapital radial head fractures. Indications for use of the I.T.S. Pelvic Reconstruktion System (PRS Phoenix) include: Fractures involving the Posterior Wall & Posterior Column, Fractures involving the Anterior Column of the Acetabulum, Fractures involving the Quadrilateral Surface, Symphyseal Disruptions & Para-symphseal Fractures, Fractures of the ilium, Fractures of the SIJ, Dorsal neutralization plating for posterior pelvic ring fractures, Osteotomies, arthrodesis and sacroiliac joint dislocations, Revision surgery of pseudoarthroses, non-unions and mal unions. The I.T.S. CTN – Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include: Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies, such as for leg length discrepancies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss.

Source page: https://510kreport.com/device/K260958
Methodology: https://510kreport.com/methodology