510(k) · Cleared
ClearedDistal Radius Fracture Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Innovations, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 5, 2002 as substantially equivalent to K982732 (Synthes, 1998) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1996. 1 of the 686 devices in its family, counting itself, has a Class I recall. 681 later devices descend from it.
- Decided
- Dec 5, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962616 (1996). 4 ancestors in all. 681 later devices descend from it, 4 citing it directly. 1 of the 686 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 1 generation backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- This deviceK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- Descendant · cites it directly · 678 of its ownK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- Descendant · 2 generations on · 615 of its ownK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- Descendant · 3 generations on · 606 of its ownK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 5 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
Showing 5 of 681 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub10 generations on · 2021
Most influential descendants
Showing 5 of 681 · See all- K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · cites it directly678descendants
- K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 2 generations on615descendants
- K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · 3 generations on606descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 4 generations on584descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 5 generations on495descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −1 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| 0 (this device) | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| +1 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| +2 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| +3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| +4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 8 | 0 |
| 2010 | 11 | 0 |
| 2011 | 13 | 0 |
| 2012 | 19 | 0 |
| 2013 | 19 | 0 |
| 2014 | 35 | 0 |
| 2015 | 35 | 0 |
| 2016 | 31 | 0 |
| 2017 | 51 | 0 |
| 2018 | 31 | 0 |
| 2019 | 37 | 0 |
| 2020 | 44 | 0 |
| 2021 | 47 | 1 |
| 2022 | 36 | 0 |
| 2023 | 49 | 0 |
| 2024 | 66 | 0 |
| 2025 | 57 | 0 |
| 2026 | 72 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS)Summary page 3…lnc. considers the modifications to this Distal Radius Fracture Repair System to be substantially equivalent to the Synthes Distal Radius Plate System, 510(k) No. K982732, with regard to the intended use, materials, biocompatibility and overall performance characteristics. The current labeling fo… | 1998 |
| * | K002775 | Distal Volar Radius Fracture Repair SystemSummary page 1…n Act of 1997 (FDAMA). The Distal Radius Fracture Repair System consists of the Distal Volar Fracture Repair System, which was previously cleared under 510(k) No. K002775. The system comprises volar stabilization plate, bone, screws, and fixation pegs. This 510(k) is being submitted as a modif… | 2000 |
What descends from it? (681)
See all 6814 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030198 (Hand Innovations, Inc., 2003) has gone furthest, with 678 descendants of its own.
- 8 other devices also cite its predicate K982732.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
This 510(k) submission will address the only the additional indicationfor use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023007: Distal Radius Fracture Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023007
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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