510(k) · Cleared
ClearedTandry Locking Plate System
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 Aug 17, 2023 as substantially equivalent to K171904 (Microware Precision Co., Ltd., 2018) after a 157-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Aug 17, 2023
- Review
- 157 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983495 (1998). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK171904 Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018
- This deviceK230690 Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK242814 Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd. · 2024 · cites it directly0descendants
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 | K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2018 | — |
| 0 (this device) | K230690 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2023 | — |
| +1 | K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K171904 | Tandry Locking Plate SystemSummary page 4…21 CFR 888.3040 Product Code: ⚫ HRS (Primary) ⚫ HWC Device Class ⚫ Class II Predicate Device Information: Primary device: Tandry Locking Plate System (K171904) Reference device: VariAx Distal Radius Plating System, VariAx 2 System (K162841)… | 2018 |
| † | K162841 | VariAx Distal Radius Plating System, VariAx 2 System | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242814 | Tandry Q-Locking Plate System | 2024 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K242814 (Microware Precision Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K171904.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. In addition, the Tandry Locking Hip Plate System is indicated for fixation of…
Read the full statement (138 words)
The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.
Each plate is indicated for the following anatomic regions:
• 1.5mm and 2.0mm locking plates – Metacarpals, metatarsals, tarsals, and phalanges
• 2.4mm locking plates – Radius, wrist, and ulna
• 3.5 mm locking plates – Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
• 5.0 mm locking plates – Femur and tibia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230690: Tandry Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230690
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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