510(k) Report

510(k) · Cleared

Cleared

Ortho Solutions Trauma Plates for Osteosysnthesis

K120360510(k) TraditionalCleared May 29, 2012113-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

Ortho Solutions Limited · HRS Plate, Fixation, Bone

Cleared on May 29, 2012 as substantially equivalent to K072411 (Aap Implantate AG, 2008) and 7 other predicates after a 113-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.

Decided
May 29, 2012
Review
113 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
8

Its longest line of descent runs back 8 generations to K962823 (1996). 59 ancestors in all, the oldest K781762 (1978). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2007: 1 other ancestor1999: 2 other ancestors1995: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestor1978: 1 other ancestor2009: 2 other ancestors2003: 3 other ancestors2001: 3 other ancestors2000: 4 other ancestors1998: 3 other ancestors1997: 2 other ancestors1984: 1 other ancestor1979: 2 other ancestors2006: 5 other ancestors2002: 4 other ancestors1986: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor1996: 4 other ancestors1994: 2 other ancestors1993: 2 other ancestors2021: 1 descendant cleared2020: 1 descendant clearedK962823 · Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer · Synthes (Usa) · 1996K993762 · I.CO.S Screw · New Deal, S.A. · 2000K024233 · Kompressor Screw System · Kinetikos Medical, Inc. · 2003K040356 · Kompressor Screw System · Kinetikos Medical, Inc. · 2004K060071 · Nexa Compression Screw · Nexa Orthopedics, Inc. · 2006K063298 · Osteomed Headless Cannulated Screw System · Osteomed LP · 2007K083912 · Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins · Treu-Instrumente GmbH · 2009K102845 · Mahe Fixation Plate and Screw System · Mahe Medical GmbH · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 12 other ancestors3 generations back: 11 other ancestors4 generations back: 12 other ancestors5 generations back: 5 other ancestors7 generations back: 1 other ancestor8 generations back: 3 other ancestors 1 generation forward: 2 descendants K102845 · Mahe Fixation Plate and Screw System · Mahe Medical GmbH · 2011K083912 · Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins · Treu-Instrumente GmbH · 2009K063298 · Osteomed Headless Cannulated Screw System · Osteomed LP · 2007K060071 · Nexa Compression Screw · Nexa Orthopedics, Inc. · 2006K040356 · Kompressor Screw System · Kinetikos Medical, Inc. · 2004K024233 · Kompressor Screw System · Kinetikos Medical, Inc. · 2003K993762 · I.CO.S Screw · New Deal, S.A. · 2000K962823 · Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer · Synthes (Usa) · 1996−50
  1. Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
  2. 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
  3. 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
  4. 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
  5. 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
  6. 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
  7. 2 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
  8. 1 generation backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
  9. This deviceK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  10. Descendant · cites it directly · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
  11. Descendant · cites it directly · 0 of its ownK210658 Volition Plating SystemOrtho Solutions UK, Ltd. · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · cites it directly1descendant
  • K210658Volition Plating SystemOrtho Solutions UK, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa)1996—
−7K993762I.CO.S ScrewNew Deal, S.A.2000—
−6K024233Kompressor Screw SystemKinetikos Medical, Inc.2003—
−5K040356Kompressor Screw SystemKinetikos Medical, Inc.2004—
−4K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006—
−3K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007—
−2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH2009—
−1K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH2011—
0 (this device)K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited2012—
+1K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.2020—
+1K210658Volition Plating SystemOrtho Solutions UK, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197920
198410
198610
199010
199210
199320
199420
199520
199640
199720
199830
199920
200040
200130
200240
200330
200410
200520
200650
200710
200820
200920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
FIG. 1 — Lineage of K120360, 1996–2021Source: 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? (8)

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
*K072411Aap Bone Plates and Screw Implants
Summary page 1
…SEQUENT PRODUCT CODE: HWC, HTN, KTT SUBSTANTIALLY EQUIVALENT DEVICES 'Bone Plates, Screws & Washers' aap Implantate AG (K(072411) 'Fixation Plate and Screw System' Mahe Medical GmbH (1(102845) 'CHS/SCS…
Aap Implantate AG2008—
*K102845Mahe Fixation Plate and Screw System
Summary page 1
…'Bone Plates, Screws & Washers' aap Implantate AG (K(072411) 'Fixation Plate and Screw System' Mahe Medical GmbH (1(102845) 'CHS/SCS System' Smith & Nephew (K993289, K921786, K(895241) 'CHS/SCS Sy…
Mahe Medical GmbH2011—
*K993289Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System
Summary page 1
…ate AG (K(072411) 'Fixation Plate and Screw System' Mahe Medical GmbH (1(102845) 'CHS/SCS System' Smith & Nephew (K993289, K921786, K(895241) 'CHS/SCS System' DePuy (K(946156) 'CHS/SCS System' Ho…
Smith & Nephew, Inc.1999—
*K921786Intramedullary Hip Screw
Summary page 1
…(072411) 'Fixation Plate and Screw System' Mahe Medical GmbH (1(102845) 'CHS/SCS System' Smith & Nephew (K993289, K921786, K(895241) 'CHS/SCS System' DePuy (K(946156) 'CHS/SCS System' Howmedica (…
Smith & Nephew Richards, Inc.1992—
*K895241Intramedullary Hip Screw
Summary page 1
…'Fixation Plate and Screw System' Mahe Medical GmbH (1(102845) 'CHS/SCS System' Smith & Nephew (K993289, K921786, K(895241) 'CHS/SCS System' DePuy (K(946156) 'CHS/SCS System' Howmedica (K(781762)…
Richards Medical Co., Inc.1990—
*K946156Depuy Compression Hip Screw System
Summary page 1
…he Medical GmbH (1(102845) 'CHS/SCS System' Smith & Nephew (K993289, K921786, K(895241) 'CHS/SCS System' DePuy (K(946156) 'CHS/SCS System' Howmedica (K(781762) 'CHS/SCS System' aap Implantate AG…
Depuy, Inc.1995—
*K781762Compression Hip Screw System
Summary page 1
…stem' Smith & Nephew (K993289, K921786, K(895241) 'CHS/SCS System' DePuy (K(946156) 'CHS/SCS System' Howmedica (K(781762) 'CHS/SCS System' aap Implantate AG (K(071852)…
Howmedica Corp.1978—
*K071852Aap Aps System
Summary page 1
…'CHS/SCS System' DePuy (K(946156) 'CHS/SCS System' Howmedica (K(781762) 'CHS/SCS System' aap Implantate AG (K(071852) Page 1 of 3 Section XII…
Aap Implantate AG2007—

Also cleared against K072411: 5 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201
K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210

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 16 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
  • 9 of the 59 ancestors have a recall of any class.
  • Of its descendants, K202764 (Ortho Solutions UK, Ltd., 2020) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K072411.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing. Ortho Solutions Bone Plates. Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small…

Read the full statement (182 words)

The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions Bone Plates. Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy.

Ortho Solutions Compression HiD Screw CHS/SCS System is indicated for fracture fixation in the proximal and distal regions of the human anatomy skeletal femur. Specific indications include: intracapsular fractures of the femoral neck; trochaneric and subtrochanteric neck fractures; osteotomies for patients with diseases or deformities of the hip;*hip arthrodesis; supracondylar fractures and distal femoral fractures.

The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.

Indications for use as stated in the FDA summary.

Also cleared against K072411

5 other devices cite the same predicate.

  • K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH · 2023
  • K182818LOQTEQ VA Calcaneus Plate 3.5Aap Implantate AG · 2019
  • K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG · 2016
  • K150974aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, TitaniumAap Implantate AG · 2015
  • K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping, TitaniumAap Implantate AG · 2014

More from Ortho Solutions Limited

6 FDA decisions under this applicant name. See the company

  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 20142 recalls
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121 recall
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20121 recall
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011

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/K120360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120360: Ortho Solutions Trauma Plates for Osteosysnthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120360

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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