510(k) Report

510(k) · Cleared

Cleared

Distal Volar Radius Fracture Repair System

K002775510(k) TraditionalCleared Dec 5, 200090-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hand Innovations, Inc. · HRS Plate, Fixation, Bone

Cleared on Dec 5, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 720 devices in its family, counting itself, has a Class I recall. 719 later devices descend from it.

Decided
Dec 5, 2000
Review
90 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

719 later devices descend from it, 8 citing it directly. 1 of the 720 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 6 descendants cleared2011: 16 descendants cleared2004: 3 descendants cleared2010: 13 descendants cleared2002: 1 descendant cleared2009: 9 descendants cleared2003: 2 descendants cleared2023: 49 descendants cleared2025: 58 descendants cleared2022: 39 descendants cleared2018: 32 descendants cleared2016: 32 descendants cleared2019: 39 descendants cleared2020: 47 descendants cleared2012: 24 descendants cleared2014: 38 descendants cleared2026: 72 descendants cleared2006: 7 descendants cleared2017: 53 descendants cleared2015: 39 descendants cleared2021: 47 descendants cleared, 1 with a Class I recall12013: 20 descendants cleared2008: 4 descendants cleared2024: 68 descendants cleared2007: 1 descendant cleared200020052010201520202025
  1. This deviceK002775 Distal Volar Radius Fracture Repair SystemHand Innovations, Inc. · 2000
  2. Descendant · cites it directly · 681 of its ownK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  3. Descendant · 2 generations on · 678 of its ownK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  4. Descendant · 3 generations on · 615 of its ownK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. Descendant · 4 generations on · 606 of its ownK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  6. Descendant · 5 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005

Showing 5 of 719 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 32005: 62006: 72007: 12008: 42009: 92010: 132011: 162012: 242013: 202014: 382015: 392016: 322017: 532018: 322019: 392020: 472021: 472022: 392023: 492024: 682025: 582026: 72
2002high 72 (2026) · low 1 (2002)2026

Class I recalls in this family

  • K211616 ExcelsiusHub11 generations on · 2021

Most influential descendants

Showing 5 of 719 · See all
  • K023007Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002 · cites it directly681descendants
  • K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 2 generations on678descendants
  • K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003 · 3 generations on615descendants
  • K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · 4 generations on606descendants
  • K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 5 generations on584descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002775Distal Volar Radius Fracture Repair SystemHand Innovations, Inc.2000—
+1K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
+2K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
+3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
+4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
+5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200430
200560
200670
200710
200840
200990
2010130
2011160
2012240
2013200
2014380
2015390
2016320
2017530
2018320
2019390
2020470
2021471
2022390
2023490
2024680
2025580
2026720
FIG. 1 — Lineage of K002775, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (719)

See all 719

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002681
K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.2005157
K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.2010119
K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115
K040908Ebi Distal Radius Plating SystemEbi, L.P.20044
K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091
K052150Volar Plate SystemDvo Extremity Solutions, LLC20050
K041461Kmi Distal Volar Radius Plate SystemKinetikos Medical, Inc.20040

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 · 11 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K023007 (Hand Innovations, Inc., 2002) has gone furthest, with 681 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

More from Hand Innovations, Inc.

10 FDA decisions under this applicant name. See the company

  • K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 20051 recall
  • K042059Shoulder Fixation SystemHand Innovations, Inc. · 2004
  • K041157Modification to Small Bone Fixation SystemHand Innovations, Inc. · 2004
  • K041081Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 20041 recall
  • K033406Small Bone Fixation SystemHand Innovations, Inc. · 2004

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K002775 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002775: Distal Volar 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/K002775

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026