510(k) · Cleared
Recalled · Class II · 2022Modified Distal Radius Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet · HRS Plate, Fixation, Bone
Cleared on Apr 1, 2014 as substantially equivalent to K112345 (Medos International SARL, 2011) and 2 other predicates after a 99-day review. Its family tree reaches back 7 generations to 1996. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 1, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962616 (1996). 10 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 1 generation backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
- This deviceK133939 Modified Distal Radius Plating SystemBiomet · 2014
- Descendant · cites it directly · 10 of its ownK161665 VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016
- Descendant · 2 generations on · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
- Descendant · 2 generations on · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K161665VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016 · cites it directly10descendants
- K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018 · 2 generations on9descendants
- K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · 2 generations on7descendants
- K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 2 generations on2descendants
- K233017TM Plating SystemTyber Medical, LLC · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −1 | K060864 | Multidirectional Threaded Peg | Hand Innovations, LLC | 2006 | — |
| 0 (this device) | K133939 | Modified Distal Radius Plating System | Biomet | 2014 | — |
| +1 | K161665 | VLP Wrist Fracture System | Smith & Nephew, Inc. | 2016 | — |
| +2 | K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | 2018 | — |
| +2 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
| +2 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +3 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K112345 | Distal Volar Radius Plating SystemsSummary page 1…The Modified Distal Radius Plating System is substantially equivalent to currently marketed Distal Volar Radius Plating System (K112345, K050932, K060864). Device Description: The Modified Distal Radius Plating System co… | 2011 |
| * | K050932 | Distal Volar Radius Anatomical Plate SystemSummary page 1…ing System is substantially equivalent to currently marketed Distal Volar Radius Plating System (K112345, K050932, K060864). Device Description: The Modified Distal Radius Plating System consists of Titanium alloy… | 2005 |
| * | K060864 | Multidirectional Threaded PegSummary page 1…m is substantially equivalent to currently marketed Distal Volar Radius Plating System (K112345, K050932, K060864). Device Description: The Modified Distal Radius Plating System consists of Titanium alloy… | 2006 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161665 | VLP Wrist Fracture System | 2016 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2022 | Class II | Z-0810-2022 | Under Investigation by firm | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find… |
| Jan 29, 2016 | Class II | Z-1082-2016 | Package design/selection | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K161665 (Smith & Nephew, Inc., 2016) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K112345.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133939: Modified Distal Radius Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133939
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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