510(k) · Cleared
ClearedDRPx Locking Distal Radius Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Implant Company · HRS Plate, Fixation, Bone
Cleared on May 6, 2021 as substantially equivalent to K123832 (The Orthopaedic Implant Company (Oic), 2013) and 2 other predicates after a 218-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it.
- Decided
- May 6, 2021
- Review
- 218 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K983495 (1998). 17 ancestors in all, the oldest K963798 (1996). 2 later devices descend from it, 2 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 deviceK202971 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021
- Descendant · cites it directly · 0 of its ownK233531 OIC FLEX-FIX™ SystemOrthopaedic Implant Company · 2024
- Descendant · cites it directly · 0 of its ownK212601 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K202971 | DRPx Locking Distal Radius Plate System | Orthopaedic Implant Company | 2021 | — |
| +1 | K233531 | OIC FLEX-FIX™ System | Orthopaedic Implant Company | 2024 | — |
| +1 | K212601 | DRPx Locking Distal Radius Plate System | Orthopaedic Implant Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K123832 | Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic Clavicle…Summary page 4…des instruments used to implant the plates. Comparison of Technological Characteristics (Substantial Equivalence): Primary predicate device: Orthopaedic Implant Company K123832 OIC Distal Radius Plating System Additional predicate devices: Skeletal Dynamics K182492 Geminus Volar Distal Radius Plat… | 2013 |
| * | K182492 | Geminus Volar Distal Radius Plate SystemSummary page 4…tial Equivalence): Primary predicate device: Orthopaedic Implant Company K123832 OIC Distal Radius Plating System Additional predicate devices: Skeletal Dynamics K182492 Geminus Volar Distal Radius Plate System. Microware K171904 Tandry Locking Plate System The… | 2018 |
| * | K171904 | Tandry Locking Plate SystemSummary page 4…Plating System Additional predicate devices: Skeletal Dynamics K182492 Geminus Volar Distal Radius Plate System. Microware K171904 Tandry Locking Plate System The DRPx Locking Distal Radius Plate System has the following similarities to those which previously… | 2018 |
What descends from it? (2)
2 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 23 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K233531 (Orthopaedic Implant Company, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123832.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202971: DRPx Locking Distal Radius Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202971
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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