510(k) · Cleared
ClearedMicroware Bone Plates and Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microware Precision Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Dec 4, 2008 as substantially equivalent to K983495 (Syntec Scientific Corp., 1998) and 2 other predicates after a 450-day review. Its family tree reaches back 2 generations to 1998. 25 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 450 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K983495 (1998). 3 ancestors in all. 25 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
- 1 generation backK063020 Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006
- This deviceK072562 Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd. · 2008
- Descendant · cites it directly · 14 of its ownK092493 GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010
- Descendant · cites it directly · 11 of its ownK171904 Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010 · cites it directly14descendants
- K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018 · cites it directly11descendants
- K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011 · 2 generations on5descendants
- K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · 2 generations on3descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… | Syntec Scientific Corp. | 1998 | — |
| −1 | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System | Intai Technology, Inc. | 2006 | — |
| 0 (this device) | 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 | — |
| +1 | K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2018 | — |
| +2 | K110086 | Ifs Profile Plates, Screws, and Washers | Internal Fixation Systems, Inc. | 2011 | — |
| +2 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120…Summary page 2…YO7256, (t.zo.zf4 Predicate Device Information: Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495) Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873) INTAI Bone Plate and Bone Screw System & INTAI DHS/DC… | 1998 |
| * | K983873 | Syntec-Taichung Non-Sterile DHS/DCS Plate SystemSummary page 2…Predicate Device Information: Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495) Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873) INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020) Materials: The non-sterile… | 1998 |
| * | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemSummary page 2…Screw Implants (K983495) Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873) INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020) Materials: The non-sterile bone plates and screws are manufactured from commercialmedical use 316L stainle… | 2006 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092493 (Gpc Medical, Ltd., 2010) has gone furthest, with 14 descendants of its own.
- 10 other devices also cite its predicate K983495.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).
Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072562: Microware Bone Plates and Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072562
Report an extraction error
Are you the manufacturer?
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