510(k) · Cleared
Recalled · 2007Drlock Distal Radius Volar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HRS Plate, Fixation, Bone
Cleared on Feb 27, 2006 as substantially equivalent to K030310 (Synthes (Usa), 2003) after a 105-day review. Its family tree reaches back 1 generation to 2003. It has been recalled 2 times.
- Decided
- Feb 27, 2006
- Review
- 105 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K030310 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030310 Synthes Stainless Steel Modular Hand SystemSynthes (Usa) · 2003
- This deviceK053182 Drlock Distal Radius Volar SystemOrthohelix Surgical Designs, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030310 | Synthes Stainless Steel Modular Hand System | Synthes (Usa) | 2003 | — |
| 0 (this device) | K053182 | Drlock Distal Radius Volar System | Orthohelix Surgical Designs, Inc. | 2006 | — |
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K002277 | FDA’s K002277 is Fresenius Optiflux 200NR Our reading of the summary gave K002277, FDA’s number for Fresenius Optiflux 200NR (Fresenius Medical Care North America). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hand Innovations Distal Volar Radius Fracture Repair System”. Kept off the family tree. Summary page 1…ssification Name Single/Multiple Component Metallic Fixation Appliances and Accessories Predicate Devices Hand Innovations Distal Volar Radius Fracture Repair System (K0022775) Synthes (USA) Stainless Steel Modular Hand System (K030310) Intended Use The system is used to stabilize and aid in the fusio… | 2000 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 1…Appliances and Accessories Predicate Devices Hand Innovations Distal Volar Radius Fracture Repair System (K0022775) Synthes (USA) Stainless Steel Modular Hand System (K030310) Intended Use The system is used to stabilize and aid in the fusion of fractures and osteotomies of the distal radius. === Pag… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2007 | Not classified | Z-0136-2008 | Component change control | Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened. |
| Aug 3, 2006 | Not classified | Z-0349-2007 | Other | The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 15 other devices also cite its predicate K030310.
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 DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053182 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053182: Drlock Distal Radius Volar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053182
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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