510(k) · Cleared
ClearedConverge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Enterprises, Inc. · HRS Plate, Fixation, Bone
Cleared on Aug 11, 2016 as substantially equivalent to K092493 (Gpc Medical, Ltd., 2010) after a 240-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Aug 11, 2016
- Review
- 240 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983495 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
- 3 generations backK063020 Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006
- 2 generations backK072562 Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd. · 2008
- 1 generation backK092493 GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010
- This deviceK153573 ConvergeBiomedical Enterprises, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… | Syntec Scientific Corp. | 1998 | — |
| −3 | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System | Intai Technology, Inc. | 2006 | — |
| −2 | K072562 | Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 2008 | — |
| −1 | K092493 | GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System | Gpc Medical, Ltd. | 2010 | — |
| 0 (this device) | K153573 | Converge | Biomedical Enterprises, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (1)
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 |
|---|---|---|---|
| * | K092493 | GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemSummary page 4…HWC – Orthopedic Devices 3. Primary Predicate: GPC Medical Bone Plates and Bone Screws K092493 Reference Device: Nitinol Compression Plating System™ K143023… | 2010 |
| † | K143023 | Nitinol Compression Plating System | 2015 |
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 18 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K092493.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153573: Converge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153573
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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