510(k) · Cleared
ClearedEmerge Medical Small Fragment Locked Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emerge Medical · HRS Plate, Fixation, Bone
Cleared on Mar 12, 2014 as substantially equivalent to K983787 (Synthes (Usa), 1999) and 3 other predicates after a 57-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 12, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K002361 (2000). 4 ancestors in all, the oldest K983787 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002361 | Synthes (Usa) Locking Proximal Plating (L-PTP) System | Synthes (Usa) | 2000 | — |
| −1 | K011978 | Synthes LCP Proximal Tibia Plate | Synthes (Usa) | 2001 | — |
| 0 (this device) | K140098 | Emerge Medical Small Fragment Locked Plating System | Emerge Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (4)
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 |
|---|---|---|---|
| * | K983787 | Synthes Proximal Tibia Plating SystemSummary page 2…icate devices listed in Table 5-2. Table 5-2 Predicate Devices 510k Trade or Proprietary or Model Manufacturer Number Name K(983787 Proximal Tibia Plating System Synthes K002361 Locking Proximal Tibia Plating(L- Synthes… | 1999 |
| * | K002361 | Synthes (Usa) Locking Proximal Plating (L-PTP) SystemSummary page 2…10k Trade or Proprietary or Model Manufacturer Number Name K(983787 Proximal Tibia Plating System Synthes K002361 Locking Proximal Tibia Plating(L- Synthes __________PTP) System KO011978 LCP Proxim… | 2000 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 2…7 Proximal Tibia Plating System Synthes K002361 Locking Proximal Tibia Plating(L- Synthes __________PTP) System KO011978 LCP Proximal Tibia Plate Synthes K001945 Medial Distal Tibia Plates Synthes P… | 2001 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 2…61 Locking Proximal Tibia Plating(L- Synthes __________PTP) System KO011978 LCP Proximal Tibia Plate Synthes K001945 Medial Distal Tibia Plates Synthes PERFORMANCE DATA Static and Dynamic Bending of the Emerge Medical Sma… | 2000 |
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 14 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K983787.
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 indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems: The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. The Emerge Medical Locking Proximal Tibia Plate Set is…
Read the full statement (102 words)
The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems:
The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge. bicondylar, combinations of lateral wedge and depression. and fractures with associated shaft fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140098: Emerge Medical Small Fragment Locked Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140098
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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