510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

I.T.S. LRS Locking Reconstruction System

K093868510(k) TraditionalCleared Aug 5, 2010231-day reviewClass II21 CFR 888.3030Recalls 1

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

I.T.S. Implantat-Technologie-Systeme GmbH · HRS Plate, Fixation, Bone

Cleared on Aug 5, 2010 as substantially equivalent to K961413 (Synthes (Usa), 1996) and 4 other predicates after a 231-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it. It has been recalled once.

Decided
Aug 5, 2010
Review
231 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
5

Its longest line of descent runs back 9 generations to K962616 (1996). 47 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors1996: 3 other ancestors2005: 4 other ancestors2003: 1 other ancestor2001: 6 other ancestors2004: 6 other ancestors2000: 6 other ancestors1999: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1998: 2 other ancestors1992: 1 other ancestor2026: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K092015 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 17 other ancestors4 generations back: 6 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 1 descendant K092015 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2009 · recalledK061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations between
  3. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  5. 1 generation backK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
  6. This deviceK093868 I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2010
  7. 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 9 generations
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 1 generation backK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
  10. This deviceK093868 I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2010

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

GenerationNumberDeviceApplicantDecidedRecalls
−9K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−8K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−7K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−6K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−1K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20091
0 (this device)K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH2010—
+1K260958I.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
198910
199010
199110
199210
199510
199630
199820
199920
200060
200160
200310
200460
200540
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K093868, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (5)

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
*K961413Synthes Anatomical Locking Plate System
Summary page 1
…. 888.3040). DEVICE PRODUCT CODE: HRS SUBSEQUENT PRODUCT CODE: HWC SUBSTANTIALLY Synthes LISS (ALPS) System (K(961413) EQUIVALENT DEVICES Stryker AxSOS Locked Plating System (KO061012) Smith&Nephew PERI-LOC Per…
Synthes (Usa)1996—
*K061012Axsos Plus Locking Plate System
Summary page 1
…RODUCT CODE: HWC SUBSTANTIALLY Synthes LISS (ALPS) System (K(961413) EQUIVALENT DEVICES Stryker AxSOS Locked Plating System (KO061012) Smith&Nephew PERI-LOC Periarticular Locked Plate (K(092015) Zimmer Peria…
Howmedica Osteonics Corp.20062
*K092015Peri-Loc Periarticular Locked Plating System
Summary page 1
…tem (K(961413) EQUIVALENT DEVICES Stryker AxSOS Locked Plating System (KO061012) Smith&Nephew PERI-LOC Periarticular Locked Plate (K(092015) Zimmer Periarticular Locking Plates and Screws (KO070906) I.T.S. GmbH St…
Smith & Nephew, Inc.20091
*K070906Modificaton to: Zimmer Periarticular Locking Plates and Screws
Summary page 1
…12) Smith&Nephew PERI-LOC Periarticular Locked Plate (K(092015) Zimmer Periarticular Locking Plates and Screws (KO070906) I.T.S. GmbH Straight Plate with Angular Stability (1K060156) DEVICE DESCRIPTION: The I.T.S.…
Zimmer, Inc.200721
*K060156Straight Plate with Angular Stability & Screw System
Summary page 1
…15) Zimmer Periarticular Locking Plates and Screws (KO070906) I.T.S. GmbH Straight Plate with Angular Stability (1K060156) DEVICE DESCRIPTION: The I.T.S. LRS (Locking Reconstruction System) consisting of the DFL (D…
I.T.S. Implantat-Technologie-Systeme GmbH20062

Also cleared against K961413: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 23, 2026Class IIZ-1603-2026No Marketing ApplicationUpdated 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 14 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
  • 18 of the 47 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.
  • 7 other devices also cite its predicate K961413.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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.TS. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less mhan or equal to 21 years old) or adult patient.

Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia.

The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

Also cleared against K961413

7 other devices cite the same predicate.

  • K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating SystemNebula Surgical Private Limited · 2019
  • K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
  • K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
  • K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
  • K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC · 2011
  • K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA · 20112 recalls

More from I.T.S. Implantat-Technologie-Systeme…

13 FDA decisions under this applicant name. See the company

  • K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008
  • K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 20081 recall
  • K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 20071 recall
  • K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 20062 recalls
  • K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 20062 recalls

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K093868 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093868: I.T.S. LRS Locking Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093868

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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