510(k) · Cleared
ClearedHand Innovations, Inc. Distal 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 Apr 1, 2003 as substantially equivalent to K023007 (Hand Innovations, Inc., 2002) after a 70-day review. Its family tree reaches back 3 generations to 1996. 1 of the 684 devices in its family, counting itself, has a Class I recall. 678 later devices descend from it.
- Decided
- Apr 1, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962616 (1996). 5 ancestors in all. 678 later devices descend from it, 4 citing it directly. 1 of the 684 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 2 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 1 generation backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- This deviceK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- Descendant · cites it directly · 615 of its ownK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- Descendant · 2 generations on · 606 of its ownK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 4 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · 5 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
Showing 5 of 678 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 678 · See all- K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · cites it directly615descendants
- K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · 2 generations on606descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 3 generations on584descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 4 generations on495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 5 generations on487descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −2 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −1 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| 0 (this device) | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| +1 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| +2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| +3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
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 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 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? (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 |
|---|---|---|---|
| * | K023007 | Distal Radius Fracture Repair SystemSummary page 1…Medical Devices Act (SMDA) 1990 and the FDA Modernization Act of 1997 (FDAMA). The Distal Radius Fracture Repair System was previously cleared under 51O(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed ang… | 2002 |
What descends from it? (678)
See all 6784 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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K032705 (Hand Innovations, Inc., 2003) has gone furthest, with 615 descendants of its own.
- 3 other devices also cite its predicate K023007.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030198
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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