510(k) · Cleared
ClearedEmerge Medical Small and Large Non-Locking Fragment 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 Jan 28, 2014 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 10 other predicates after a 71-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Jan 28, 2014
- Review
- 71 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 5 generations to K981372 (1998). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 1 generation backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- This deviceK133541 Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −1 | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| 0 (this device) | K133541 | Emerge Medical Small and Large Non-Locking Fragment Plate System | Emerge Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2013 | 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? (12)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…Devices Panel Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) Synthes Modular Fooi System (KOO01941)… | 2000 |
| * | K001941 | Synthes Modular Foot System | 2000 |
| * | K010766 | Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T PlateSummary page 1…em (KOO01941) Synthes Large Fragment Locking Compression Plate (LCP) - T-Plate (K010766) Synthes 3.5mnm Broad LC-DCP Plates (K020872)Synthes 3.5… | 2001 |
| * | K020872 | Synthes 3.5 MM Broad LC-DCP PlatesSummary page 1…Compression Plate (LCP) - T-Plate (K010766) Synthes 3.5mnm Broad LC-DCP Plates (K020872)Synthes 3.5 and 4.5mm Locking Compression Plate LCP with Expanded Predicate Devic… | 2002 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…)Synthes 3.5 and 4.5mm Locking Compression Plate LCP with Expanded Predicate Devices: Indications (K082807) Synthes 3.5 and 4.5 Curved Nar-row and Broad LCP (K(092609)… | 2008 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 1…anded Predicate Devices: Indications (K082807) Synthes 3.5 and 4.5 Curved Nar-row and Broad LCP (K(092609) Synthes Medial Distal Tibia Plates (1(001945)… | 2009 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 1…Synthes 3.5 and 4.5 Curved Nar-row and Broad LCP (K(092609) Synthes Medial Distal Tibia Plates (1(001945) Synthes Calcaneal Plate (K(020401, K(010518)… | 2000 |
| * | K020401 | Synthes Calcaneal PlateSummary page 1…92609) Synthes Medial Distal Tibia Plates (1(001945) Synthes Calcaneal Plate (K(020401, K(010518) Synthes Reconstructive Y-Plate (K79229 1)… | 2002 |
| * | K010518 | Synthes Anterolateral Calcaneal PlateSummary page 1…Synthes Medial Distal Tibia Plates (1(001945) Synthes Calcaneal Plate (K(020401, K(010518) Synthes Reconstructive Y-Plate (K79229 1)… | 2001 |
| Kept off the family tree | K079291 | Synthes Reconstructive Y-Plate Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 1…8) Synthes Reconstructive Y-Plate (K79229 1) Synthes LCP Distal Tibia.Plates (1(013248) OrthoPro Ankle Trauma System (K 122936) DESCRIPTION OF THE DEVICE SUBJECT TO PREMA… | 2001 |
| * | K122936 | Ankle Trauma SystemSummary page 1…229 1) Synthes LCP Distal Tibia.Plates (1(013248) OrthoPro Ankle Trauma System (K 122936) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION The Emerge Medical Small and Large Non-Locking Fragment Plate Syste… | 2013 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 68 other devices also cite its predicate K000684.
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 Large Plate System is intended for fixation for fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone.
The Emerge Medical Small Plate System is intended for fixation for fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133541: Emerge Medical Small and Large Non-Locking Fragment Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133541
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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