510(k) Report

510(k) · Cleared

Cleared

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

K260958510(k) TraditionalCleared Jun 16, 202685-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year cleared 2022: 1 other ancestor2014: 1 other ancestor2013: 2 other ancestors2010: 7 other ancestors2008: 9 other ancestors2007: 12 other ancestors2006: 17 other ancestors2005: 22 other ancestors2004: 19 other ancestors2012: 5 other ancestors2011: 4 other ancestors2009: 11 other ancestors2003: 15 other ancestors2002: 17 other ancestors2001: 22 other ancestors2000: 17 other ancestors1999: 9 other ancestors1998: 13 other ancestors1997: 6 other ancestors1996: 21 other ancestors1995: 10 other ancestors1992: 8 other ancestors1990: 2 other ancestors1986: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestors1994: 6 other ancestors1993: 3 other ancestors1979: 1 other ancestor1980: 1 other ancestor1981: 1 other ancestorK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K131722 · I.T.S. Extremity Fixation Systems · I.T.S. GmbH · 2013 · recalledK142418 · I.T.S. Hand Locking Plates System - HLS · I.T.S. GmbH · 2014 · recalled19801990200020102020
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  4. 2 generations backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  5. 1 generation backK142418 I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 2014 · Recalled
  6. This deviceK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 2 generations backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  12. 1 generation backK142418 I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 2014 · Recalled
  13. 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

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132
−1K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH20141
0 (this device)K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with…I.T.S. GmbH2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198110
198610
198940
199020
199110
199280
199330
199460
1995100
1996210
199760
1998130
199990
2000170
2001220
2002170
2003150
2004190
2005220
2006170
2007120
200890
2009110
201070
201140
201250
201320
201410
202210
FIG. 1 — Lineage of K260958, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K050852Claviculaplate with Angular Stablity Bone Plate System
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K033756Volar Radius Plate with Angular Stability
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20041
*K051412Humeral Head Plate with Angular Stability
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K051642FR.O.H. Calcaneus Repair System
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K052011Pilonplate with Angular Stability
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K052368Olecranonplate with Angular Stability
Summary 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.…
I.T.S. Implantat-Technologie-Systeme GmbH20051
*K060156Straight Plate with Angular Stability & Screw System
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20062
*K063166I.T.S. Pelvic Reconstruction System
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20062
*K063672Fibula Plate Prolock with Angular Stability
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20071
*K080184Distal Humeral Plates with Angular Stability
Summary 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.…
I.T.S. Implantat-Technologie-Systeme GmbH20081
*K093868I.T.S. LRS Locking Reconstruction System
Summary 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…
I.T.S. Implantat-Technologie-Systeme GmbH20101
*K130008Distal 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…
I.T.S. GmbH20131
*K131722I.T.S. Extremity Fixation Systems
Summary 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…
I.T.S. GmbH20132
*K142418I.T.S. Hand Locking Plates System - HLS
Summary 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…
I.T.S. GmbH20141
*K210935I.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…
I.T.S. GmbH20221
*K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail
Summary 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…
I.T.S. GmbH2014—

Also cleared against K050852: 3 other devices →

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 devices

HRS 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

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

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.

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

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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