510(k) · Cleared
ClearedI.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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.T.S. GmbH · HRS Plate, Fixation, Bone
Cleared on Jun 16, 2026 as substantially equivalent to K050852 (I.T.S. Implantat-Technologie-Systeme GmbH, 2005) and 15 other predicates after an 85-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Jun 16, 2026
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 12 generations to K962616 (1996). 280 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- 1 generation backK142418 I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 2014 · Recalled
- This deviceK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- 1 generation backK142418 I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 2014 · Recalled
- This deviceK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| −1 | K142418 | I.T.S. Hand Locking Plates System - HLS | I.T.S. GmbH | 2014 | 1 |
| 0 (this device) | K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with… | I.T.S. GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 8 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 10 | 0 |
| 1996 | 21 | 0 |
| 1997 | 6 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 17 | 0 |
| 2001 | 22 | 0 |
| 2002 | 17 | 0 |
| 2003 | 15 | 0 |
| 2004 | 19 | 0 |
| 2005 | 22 | 0 |
| 2006 | 17 | 0 |
| 2007 | 12 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (16)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050852 | Claviculaplate with Angular Stablity Bone Plate SystemSummary page 9…I.T.S. GmbH MR Conditional SUBSTANTIAL EQUIVALENCE: PRIMARY PREDICATE I.T.S. Clavicle Plates with Angular Stability (K050852) ADDITIONAL PREDICATES I.T.S. Volar Radius Plate with Angular Stability (K033756) I.T.S. Humeral Head Plate with Angular Stabili… | 2005 |
| * | K033756 | Volar Radius Plate with Angular StabilitySummary page 9…AL EQUIVALENCE: PRIMARY PREDICATE I.T.S. Clavicle Plates with Angular Stability (K050852) ADDITIONAL PREDICATES I.T.S. Volar Radius Plate with Angular Stability (K033756) I.T.S. Humeral Head Plate with Angular Stability (K051412) I.T.S. FR.O.H. Calcaneus Repair System (K051642) I.T.S. Pilonplate wi… | 2004 |
| * | K051412 | Humeral Head Plate with Angular StabilitySummary page 9…ates with Angular Stability (K050852) ADDITIONAL PREDICATES I.T.S. Volar Radius Plate with Angular Stability (K033756) I.T.S. Humeral Head Plate with Angular Stability (K051412) I.T.S. FR.O.H. Calcaneus Repair System (K051642) I.T.S. Pilonplate with Angular Stability (K052011) I.T.S. Olecranonplate with A… | 2005 |
| * | K051642 | FR.O.H. Calcaneus Repair SystemSummary page 9…PREDICATES I.T.S. Volar Radius Plate with Angular Stability (K033756) I.T.S. Humeral Head Plate with Angular Stability (K051412) I.T.S. FR.O.H. Calcaneus Repair System (K051642) I.T.S. Pilonplate with Angular Stability (K052011) I.T.S. Olecranonplate with Angular Stability (K052368) I.T.S. Straight Plate… | 2005 |
| * | K052011 | Pilonplate with Angular StabilitySummary page 9…Stability (K033756) I.T.S. Humeral Head Plate with Angular Stability (K051412) I.T.S. FR.O.H. Calcaneus Repair System (K051642) I.T.S. Pilonplate with Angular Stability (K052011) I.T.S. Olecranonplate with Angular Stability (K052368) I.T.S. Straight Plate with Angular Stability (K060156) I.T.S. Screw Syste… | 2005 |
| * | K052368 | Olecranonplate with Angular StabilitySummary page 9…lar Stability (K051412) I.T.S. FR.O.H. Calcaneus Repair System (K051642) I.T.S. Pilonplate with Angular Stability (K052011) I.T.S. Olecranonplate with Angular Stability (K052368) I.T.S. Straight Plate with Angular Stability (K060156) I.T.S. Screw System (K060156) I.T.S. PRS Sacral Rod System (K063166) I.T.… | 2005 |
| * | K060156 | Straight Plate with Angular Stability & Screw SystemSummary page 9…System (K051642) I.T.S. Pilonplate with Angular Stability (K052011) I.T.S. Olecranonplate with Angular Stability (K052368) I.T.S. Straight Plate with Angular Stability (K060156) I.T.S. Screw System (K060156) I.T.S. PRS Sacral Rod System (K063166) I.T.S. Fibula Plate PROlock with Angular Stability (K063672… | 2006 |
| * | K063166 | I.T.S. Pelvic Reconstruction SystemSummary page 9…I.T.S. Olecranonplate with Angular Stability (K052368) I.T.S. Straight Plate with Angular Stability (K060156) I.T.S. Screw System (K060156) I.T.S. PRS Sacral Rod System (K063166) I.T.S. Fibula Plate PROlock with Angular Stability (K063672) I.T.S. Distal Humeral Plates with Angular Stability (K080184) I.T.S… | 2006 |
| * | K063672 | Fibula Plate Prolock with Angular StabilitySummary page 9…Straight Plate with Angular Stability (K060156) I.T.S. Screw System (K060156) I.T.S. PRS Sacral Rod System (K063166) I.T.S. Fibula Plate PROlock with Angular Stability (K063672) I.T.S. Distal Humeral Plates with Angular Stability (K080184) I.T.S. LRS (Locking Reconstruction System) – DFL (Distal Femur Loc… | 2007 |
| * | K080184 | Distal Humeral Plates with Angular StabilitySummary page 9…System (K060156) I.T.S. PRS Sacral Rod System (K063166) I.T.S. Fibula Plate PROlock with Angular Stability (K063672) I.T.S. Distal Humeral Plates with Angular Stability (K080184) I.T.S. LRS (Locking Reconstruction System) – DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) (K093868) I.T.S.… | 2008 |
| * | K093868 | I.T.S. LRS Locking Reconstruction SystemSummary page 9…S. Distal Humeral Plates with Angular Stability (K080184) I.T.S. LRS (Locking Reconstruction System) – DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) (K093868) I.T.S. Ulna Locking Plates – (DUL & UOL) Systems (K130008) I.T.S. FLS – Foot Locking Plates System (K131722) I.T.S. HCS – Headle… | 2010 |
| * | K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…Summary page 9….T.S. LRS (Locking Reconstruction System) – DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) (K093868) I.T.S. Ulna Locking Plates – (DUL & UOL) Systems (K130008) I.T.S. FLS – Foot Locking Plates System (K131722) I.T.S. HCS – Headless Compression Screw System (K131722) I.T.S. HOL – Hallux O… | 2013 |
| * | K131722 | I.T.S. Extremity Fixation SystemsSummary page 9…istal Femur Locking) & PTL (Proximal Lateral Tibia Locking) (K093868) I.T.S. Ulna Locking Plates – (DUL & UOL) Systems (K130008) I.T.S. FLS – Foot Locking Plates System (K131722) I.T.S. HCS – Headless Compression Screw System (K131722) I.T.S. HOL – Hallux Osteotomy Locking Plate (K131722) I.T.S. Twist-Off… | 2013 |
| * | K142418 | I.T.S. Hand Locking Plates System - HLSSummary page 9…dless Compression Screw System (K131722) I.T.S. HOL – Hallux Osteotomy Locking Plate (K131722) I.T.S. Twist-Off Screws (K131722) I.T.S. Hand Locking Plates System – HLS (K142418) I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (K210935) I.T.S. CTN – Cannulated Tibia Nail System (K132945) DEVICE… | 2014 |
| * | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)Summary page 9…y Locking Plate (K131722) I.T.S. Twist-Off Screws (K131722) I.T.S. Hand Locking Plates System – HLS (K142418) I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (K210935) I.T.S. CTN – Cannulated Tibia Nail System (K132945) DEVICE DESCRIPTION: The purpose of this Traditional 510(k) is t… | 2022 |
| * | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailSummary page 9…131722) I.T.S. Hand Locking Plates System – HLS (K142418) I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (K210935) I.T.S. CTN – Cannulated Tibia Nail System (K132945) DEVICE DESCRIPTION: The purpose of this Traditional 510(k) is to add the updated MR conditional… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 77 of the 280 ancestors have a recall of any class.
- 3 other devices also cite its predicate K050852.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
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…
Read the full statement (1,804 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260958 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260958
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026