510(k) · Cleared
ClearedEmerge Medical Bone Plate 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 Feb 26, 2014 as substantially equivalent to K030310 (Synthes (Usa), 2003) and 5 other predicates after a 100-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 26, 2014
- Review
- 100 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K000684 (2000). 7 ancestors in all. 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 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| 0 (this device) | K133536 | Emerge Medical Bone Plate System | Emerge Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (6)
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 |
|---|---|---|---|
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 2…dicate devices listed in Table 5.1 Predicate Devices. Table 5.1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer K0303 10 Synthes Modular Hand System Synthes KOO01941 Synthes Modular Foot System… | 2003 |
| * | K001941 | Synthes Modular Foot System | 2000 |
| * | K020401 | Synthes Calcaneal PlateSummary page 2…cturer K0303 10 Synthes Modular Hand System Synthes KOO01941 Synthes Modular Foot System Synthes K020401 Synthes Calcaneal Plate Synthes K063049 Synthes Mini Fragment LCP System… | 2002 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 2…ynthes KOO01941 Synthes Modular Foot System Synthes K020401 Synthes Calcaneal Plate Synthes K063049 Synthes Mini Fragment LCP System Synthes K01 1335 Synthes One-Third DCL Plate… | 2006 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 2…ynthes K020401 Synthes Calcaneal Plate Synthes K063049 Synthes Mini Fragment LCP System Synthes K01 1335 Synthes One-Third DCL Plate Synthes K010321 Synthes Modular Foot Systeni-2.7mm M… | 2001 |
| * | K010321 | Modular Foot System - 2.7 MM ModuleSummary page 2…ynthes K063049 Synthes Mini Fragment LCP System Synthes K01 1335 Synthes One-Third DCL Plate Synthes K010321 Synthes Modular Foot Systeni-2.7mm Module Synthes PERFORMANCE DATA The Emerge Medical Bone Plate System h… | 2001 |
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.
- 4 of the 7 ancestors have a recall of any class.
- 15 other devices also cite its predicate K030310.
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 Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone. The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations…
Read the full statement (143 words)
The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.
The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations of small bones and bone fragments including tarsals, metatarsals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.
The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones.
The Emerge Medical Modular Foot System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133536: Emerge Medical Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133536
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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