510(k) · Cleared
Recalled · Class II · 2014Dorsal Nail Plate, Anatomical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Innovations, LLC · HRS Plate, Fixation, Bone
Cleared on Sep 14, 2005 as substantially equivalent to K023007 (Hand Innovations, Inc., 2002) after a 27-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 14, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962616 (1996). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- 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 deviceK052248 Dorsal Nail Plate, AnatomicalHand Innovations, LLC · 2005
- Descendant · cites it directly · 2 of its ownK120015 Osteomed Wrist Plating SystemOsteomed LP · 2012
- Descendant · 2 generations on · 1 of its ownK152145 OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2015
- Descendant · 3 generations on · 0 of its ownK161041 OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2016
Most influential descendants
Showing 3 of 3 · See allView 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) | K052248 | Dorsal Nail Plate, Anatomical | Hand Innovations, LLC | 2005 | — |
| +1 | K120015 | Osteomed Wrist Plating System | Osteomed LP | 2012 | — |
| +2 | K152145 | OsteoMed ExtremiLOCK Wrist Plating System | Osteomed | 2015 | — |
| +3 | K161041 | OsteoMed ExtremiLOCK Wrist Plating System | Osteomed | 2016 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (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…device is substantially equivalent to: Predicate * Dorsal Nail Plate of the Distal Radius Fracture Repair System (510(,k)# Devices K023007 - December 5, 2002) - Hand Innovations, Inc. Classification Class II. Performance Performance standards have… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120015 | Osteomed Wrist Plating System | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2014 | Class II | Z-2212-2014 | Nonconforming Material/Component | The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck. |
| Dec 23, 2008 | Not classified | Z-0981-2009 | Device Design | The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately. |
| Dec 23, 2008 | Not classified | Z-0982-2009 | Device Design | The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately. |
| Dec 23, 2008 | Not classified | Z-0983-2009 | Device Design | The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately. |
| Dec 23, 2008 | Not classified | Z-0984-2009 | Device Design | The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120015 (Osteomed LP, 2012) has gone furthest, with 2 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 Dorsal Nail PlateTM, Anatomical 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/K052248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052248: Dorsal Nail Plate, Anatomical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052248
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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