510(k) · Cleared
Recalled · Class II · 2026I.T.S. Hand Locking Plates System - HLS
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 Sep 26, 2014 as substantially equivalent to K961497 (Howmedica, Inc., 1996) and 6 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 26, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 11 generations to K962616 (1996). 157 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- This deviceK142418 I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 2014
- Descendant · cites it directly · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- This deviceK142418 I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH · 2014
Most influential descendants
Showing 1 of 1 · See all- K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| 0 (this device) | K142418 | I.T.S. Hand Locking Plates System - HLS | I.T.S. GmbH | 2014 | — |
| +1 | 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 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 14 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 11 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K961497 | Profyle Titanium Hand and Small Fragment SystemSummary page 4…Fixation Appliances and Accessories (per 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: KTT, HWC SUBSTANTIALLY Stryker — Hand Plating System (K961497 & K060613) EQUIVALENT DEVICES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K1… | 1996 |
| * | K060613 | Variax Locking Plate SystemSummary page 4…ppliances and Accessories (per 21 CRF, Sec. 888.3030). DEVICE PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: KTT, HWC SUBSTANTIALLY Stryker — Hand Plating System (K961497 & K060613) EQUIVALENT DEVICES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K06… | 2006 |
| * | K092247 | Synthes Locking Hand PlatesSummary page 4…PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: KTT, HWC SUBSTANTIALLY Stryker — Hand Plating System (K961497 & K060613) EQUIVALENT DEVICES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081) I.T.S. GmbH - Extremity Fixation Systems (K131… | 2009 |
| * | K101240 | Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…Summary page 4…LLY Stryker — Hand Plating System (K961497 & K060613) EQUIVALENT DEVICES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081) I.T.S. GmbH - Extremity Fixation Systems (K131722) DEVICE DESCRIPTION: The LT.S. Hand Locking Plates System… | 2010 |
| * | K061748 | Fragment Plate SystemSummary page 4…er — Hand Plating System (K961497 & K060613) EQUIVALENT DEVICES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081) I.T.S. GmbH - Extremity Fixation Systems (K131722) DEVICE DESCRIPTION: The LT.S. Hand Locking Plates System — HLS co… | 2006 |
| * | K041081 | Fragment Plate System, Screws, Pins and K-WiresSummary page 4…Plating System (K961497 & K060613) EQUIVALENT DEVICES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081) I.T.S. GmbH - Extremity Fixation Systems (K131722) DEVICE DESCRIPTION: The LT.S. Hand Locking Plates System — HLS consists of… | 2004 |
| * | K131722 | I.T.S. Extremity Fixation SystemsSummary page 4…CES Synthes — LCP Compact Hand 1.5 (K092247) Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081) I.T.S. GmbH - Extremity Fixation Systems (K131722) DEVICE DESCRIPTION: The LT.S. Hand Locking Plates System — HLS consists of Predicate small bone trauma implant components comm… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2026 | Class II | Z-1607-2026 | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 157 ancestors have a recall of any class.
- Of its descendants, K260958 (I.T.S. GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K961497.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 intended use of the I.T.S. Hand Locking Plates System — HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient.
The I.T.S. Hand Locking Plates 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.
The I.T.S. Hand Locking Plates System is not for spinal use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142418: I.T.S. Hand Locking Plates System - HLS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142418
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026