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 Sep 18, 2018 as substantially equivalent to K072562 (Microware Precision Co., Ltd., 2008) and 6 other predicates after a 449-day review. Its family tree reaches back 3 generations to 1998. 11 later devices descend from it.
- Decided
- Sep 18, 2018
- Review
- 449 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K983495 (1998). 11 ancestors in all. 11 later devices descend from it, 7 citing it directly.
- 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 deviceK171904 Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · cites it directly · 2 of its ownK202971 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021
- Descendant · cites it directly · 1 of its ownK230690 Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK223118 OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2023
- Descendant · 2 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · cites it directly2descendants
- K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021 · cites it directly2descendants
- K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2023 · cites it directly1descendant
- K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2023 · cites it directly1descendant
- K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 2 generations on0descendants
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) | K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2018 | — |
| +1 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +1 | K202971 | DRPx Locking Distal Radius Plate System | Orthopaedic Implant Company | 2021 | — |
| +1 | K230690 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2023 | — |
| +1 | K223118 | OIC Variable Angle Small Fragment Locking Plate System | Orthopaedic Implant Company | 2023 | — |
| +2 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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? (7)
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 4…, 21 CFR 888.3030 and 21 CFR 888.3040 Product Code: HWC and HRS Predicate Device Information: Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System (K072562) Synthes LCP Distal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proxima… | 2008 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 4…oduct Code: HWC and HRS Predicate Device Information: Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System (K072562) Synthes LCP Distal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal… | 2006 |
| * | K023802 | Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSummary page 4…one Plates and Bone Screws & Microware DHS/DCS Plate System (K072562) Synthes LCP Distal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP Sys… | 2003 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 4…DCS Plate System (K072562) Synthes LCP Distal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP System (K063049) Synthes (USA) 1.5mm Mini Frag… | 2001 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 4…tal Femur Plates (K062564) Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP System (K063049) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) Device Descrip… | 2001 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 4…ximal Tibia Plating System (K023802) Synthes LCP Proximal Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP System (K063049) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) Device Description: The Tandry Locking Plate System consists of various… | 2006 |
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 4…al Tibia Plate (K011978) Synthes LCP Distal Tibia Plates (K013248) Synthes (USA) Modular Mini Fragment LCP System (K063049) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) Device Description: The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are d… | 2009 |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242939 | ARTFX Trauma Bone Plate and Screw System | 2024 | 2 |
| K202971 | DRPx Locking Distal Radius Plate System | 2021 | 2 |
| K230690 | Tandry Locking Plate System | 2023 | 1 |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | 2023 | 1 |
| K242814 | Tandry Q-Locking Plate System | 2024 | 0 |
| K242995 | OIC Small / Mini Fragment Plate System | 2024 | 0 |
| K220359 | Tandry Compression Screw System | 2022 | 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 20 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K242939 (Artfx Medical, 2024) has gone furthest, with 2 descendants of its own.
- 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. 2018, 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?
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. In addition, Tandry Locking Hip Plate System is intended for use in fixation of fractures to the proximal femur. The plates…
Read the full statement (135 words)
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, Tandry Locking Hip Plate System is intended for use in 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 to be used in 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/K171904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171904: 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/K171904
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