510(k) · Cleared
ClearedMicroware Bone Plates and Bone Screw
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 May 2, 2012 as substantially equivalent to K072562 (Microware Precision Co., Ltd., 2008) and 4 other predicates after a 387-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- May 2, 2012
- Review
- 387 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K983495 (1998). 10 ancestors in all, the oldest K914472 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
- 2 generations backK063020 Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006
- 1 generation backK072562 Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd. · 2008
- This deviceK111008 Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… | Syntec Scientific Corp. | 1998 | — |
| −2 | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System | Intai Technology, Inc. | 2006 | — |
| −1 | K072562 | Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 2008 | — |
| 0 (this device) | K111008 | Microware Bone Plates and Bone Screw | Microware Precision Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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? (5)
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 |
|---|---|---|---|
| * | K072562 | Microware Bone Plates and Bone ScrewsSummary page 1…on, nail/blade/plate combination, multiple component-KiT Predicate Device Information: Microware Bone Plates and Bone Screws (K072562) Kens Internal Fixation System (K090786) Synthes 2.4mm Cannulated Screw (1(012945) Synthes Metallic Spiked Washers (1(013806) Syn… | 2008 |
| * | K090786 | Kens Internal Fixation SystemSummary page 1…multiple component-KiT Predicate Device Information: Microware Bone Plates and Bone Screws (K072562) Kens Internal Fixation System (K090786) Synthes 2.4mm Cannulated Screw (1(012945) Synthes Metallic Spiked Washers (1(013806) Synthes Spherical Washers (K(052483)… | 2009 |
| * | K012945 | Synthes 2.4 MM Cannulated ScrewSummary page 1…e component-KiT Predicate Device Information: Microware Bone Plates and Bone Screws (K072562) Kens Internal Fixation System (K090786) Synthes 2.4mm Cannulated Screw (1(012945) Synthes Metallic Spiked Washers (1(013806) Synthes Spherical Washers (K(052483)… | 2001 |
| * | K013806 | Synthes Metallic Spiked WashersSummary page 1…ion: Microware Bone Plates and Bone Screws (K072562) Kens Internal Fixation System (K090786) Synthes 2.4mm Cannulated Screw (1(012945) Synthes Metallic Spiked Washers (1(013806) Synthes Spherical Washers (K(052483) .5… | 2002 |
| * | K052483 | Synthes (Usa) Spherical WashersSummary page 1…crews (K072562) Kens Internal Fixation System (K090786) Synthes 2.4mm Cannulated Screw (1(012945) Synthes Metallic Spiked Washers (1(013806) Synthes Spherical Washers (K(052483) .5 510… | 2005 |
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 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K072562.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Bone Plates and Bone Screws Accessonies: I1. The round washer is used to increase bone contact area for distributing the forces/load and…
Read the full statement (148 words)
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 Bone Plates and Bone Screws Accessonies:
I1. The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
2. The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles.
3. The spiked washer is used for ligament reattachment or fixation.
4. The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111008: Microware Bone Plates and Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111008
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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