510(k) Report

510(k) · Cleared

Cleared

Emerge Medical Periarticular and Locking Large Fragment System

K140119510(k) TraditionalCleared Mar 12, 201455-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

Emerge Medical · HRS Plate, Fixation, Bone

Cleared on Mar 12, 2014 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 10 other predicates after a 55-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.

Decided
Mar 12, 2014
Review
55 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
11

Its longest line of descent runs back 4 generations to K981372 (1998). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2009: 1 other ancestor2006: 1 other ancestor2004: 2 other ancestors2001: 2 other ancestors2000: 4 other ancestors1999: 2 other ancestors1998: 1 other ancestor2014: 1 descendant clearedK981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998K991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 4 other ancestors 1 generation forward: 1 descendant K082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 19980
  1. Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
  2. 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
  3. 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  5. This deviceK140119 Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical · 2014
  6. Descendant · cites it directly · 0 of its ownK141347 Emerge Medical IM Nail SystemEmerge Medical · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K141347Emerge Medical IM Nail SystemEmerge Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K981372Synthes 3.0 MM PC-Fix SystemSynthes (Usa)1998—
−3K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999—
−2K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
−1K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
0 (this device)K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical2014—
+1K141347Emerge Medical IM Nail SystemEmerge Medical2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200040
200120
200420
200610
200910
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K140119, 1998–2014Source: 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? (11)

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
*K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications
Summary page 2
…ed in Table 5-1 Predicate Devices. Table 5-1 Predicate Devices 510Ok Number Trade or Proprietary or Model Name Manufacturer K(082807 3.5mm and 4.5mm Locking Compression Plate (LCP) Synthes Systm…
Synthes (Usa)2008—
*K000682Synthes Large Fragment Dynamic Compression Locking (DCL) System
Summary page 2
…5mm and 4.5mm Locking Compression Plate (LCP) Synthes Systm wih Exanded Indications K(000682, K041911 Locking Fragment Dynamic Compression Locking (DCL) Synthes Syste,…
Synthes (Usa)2000—
*K041911Synthes (Usa) LCP Curved Plates
Summary page 2
…4.5mm Locking Compression Plate (LCP) Synthes Systm wih Exanded Indications K(000682, K041911 Locking Fragment Dynamic Compression Locking (DCL) Synthes Syste,…
Synthes (Usa)20041
*K000066Synthes (Usa) Locking Condylar Plate (LCP) System
Summary page 2
…Locking Fragment Dynamic Compression Locking (DCL) Synthes Syste, LCPCurvd Plates K(000066 Locking Condylar Plate (LCP) System Synthes 1K110354,1K083025 4.5mm VA-L…
Synthes (Usa)2000—
*K1103544.5MM VA-LCP Curved Condylar Plate System
Summary page 2
…Syste, LCPCurvd Plates K(000066 Locking Condylar Plate (LCP) System Synthes 1K110354,1K083025 4.5mm VA-LCP Curved Condylar Plate System Synthes K062564 ILCP Distal…
Synthes USA20112
*K083025Synthes 4.5 MM VA-LCP Curved Condylar System
Summary page 2
…yste, LCPCurvd Plates K(000066 Locking Condylar Plate (LCP) System Synthes 1K110354,1K083025 4.5mm VA-LCP Curved Condylar Plate System Synthes K062564 ILCP Distal Femur Pl…
Synthes (Usa)2009—
*K062564Synthes LCP Distal Femur Plates
Summary page 2
…Locking Condylar Plate (LCP) System Synthes 1K110354,1K083025 4.5mm VA-LCP Curved Condylar Plate System Synthes K062564 ILCP Distal Femur Plate Synthes K010766 Large Fra…
Synthes (Usa)2006—
*K010766Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate
Summary page 2
…4.5mm VA-LCP Curved Condylar Plate System Synthes K062564 ILCP Distal Femur Plate Synthes K010766 Large Fragment Locking Compression Plate (LCP) System Synthes -T Plate…
Synthes (Usa)2001—
*K011978Synthes LCP Proximal Tibia PlateSynthes (Usa)2001—
*K002361Synthes (Usa) Locking Proximal Plating (L-PTP) System
Summary page 2
…Large Fragment Locking Compression Plate (LCP) System Synthes -T Plate - KOl 1978, K(002361, LCP Proximal Tibia Plate, Locking Proximal Tibia Plating Synthes _K983787 (L-PTP)System,_Proxi…
Synthes (Usa)2000—
*K983787Synthes Proximal Tibia Plating System
Summary page 2
…-T Plate - KOl 1978, K(002361, LCP Proximal Tibia Plate, Locking Proximal Tibia Plating Synthes _K983787 (L-PTP)System,_ProximalTibiaPlatingSystem _______ PERFORMANCE DATA The Emerge Medical…
Synthes (Usa)1999—

Also cleared against K082807: 42 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
K141347Emerge Medical IM Nail SystemEmerge Medical20140

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 3 companies; a new generation was cleared every 5.0 years on median.
  • 5 of the 18 ancestors have a recall of any class.
  • Of its descendants, K141347 (Emerge Medical, 2014) has gone furthest, with 0 descendants of its own.
  • 42 other devices also cite its predicate K082807.

How does its category compare?

All HRS devices

HRS 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

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 indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems: The Emerge Medical Periarticular Lacking Plate Set is intended for treatment of nonunions. mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft…

Read the full statement (158 words)

The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems:

The Emerge Medical Periarticular Lacking Plate Set is intended for treatment of nonunions. mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures, fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.

The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.

Indications for use as stated in the FDA summary.

Also cleared against K082807

42 other devices cite the same predicate.

  • K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026
  • K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH · 2026
  • K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
  • K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
  • K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd. · 2025
  • K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior…Bonebridge AG · 2024

More from Emerge Medical

10 FDA decisions under this applicant name. See the company

  • K141347Emerge Medical IM Nail SystemEmerge Medical · 2014
  • K140107Emerge Medical Distal Radius SetEmerge Medical · 2014
  • K140098Emerge Medical Small Fragment Locked Plating SystemEmerge Medical · 2014
  • K133536Emerge Medical Bone Plate SystemEmerge Medical · 2014
  • K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical · 2014

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/K140119 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140119: Emerge Medical Periarticular and Locking Large Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140119

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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