510(k) · Cleared
ClearedDepuy Synthes Variable Angle Locking Hand System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA · HRS Plate, Fixation, Bone
Cleared on Mar 30, 2015 as substantially equivalent to K090047 (Synthes (Usa), 2009) and 5 other predicates after a 294-day review. Its family tree reaches back 10 generations to 1996. 7 later devices descend from it.
- Decided
- Mar 30, 2015
- Review
- 294 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K962616 (1996). 97 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK141527 Depuy Synthes Variable Angle Locking Hand SystemSynthes USA · 2015
- Descendant · cites it directly · 1 of its ownK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK200043 Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range…Field Orthopaedics Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253906 Xpert HandNewclip Technics · 2026
- Descendant · 2 generations on · 0 of its ownK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK242814 Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK141527 Depuy Synthes Variable Angle Locking Hand SystemSynthes USA · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023 · cites it directly1descendant
- K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd. · 2020 · cites it directly1descendant
- K253906Xpert HandNewclip Technics · 2026 · cites it directly0descendants
- K242348Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024 · 2 generations on0descendants
- K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | 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 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| 0 (this device) | K141527 | Depuy Synthes Variable Angle Locking Hand System | Synthes USA | 2015 | — |
| +1 | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +1 | K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate… | Field Orthopaedics Pty, Ltd. | 2020 | — |
| +1 | K253906 | Xpert Hand | Newclip Technics | 2026 | — |
| +2 | K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 | — |
| +1 | K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 4…m Name: Classification: Classification: §888.3030, §888.3040 Product Code: HRS, HWC Predicate Synthes 1.5mm LCP Mini-Fragment System (K090047) Device: Synthes Locking Hand Plates (K092247) Synthes Stainless Steel Modular Hand System (K030310… | 2009 |
| * | K092247 | Synthes Locking Hand PlatesSummary page 4…888.3040 Product Code: HRS, HWC Predicate Synthes 1.5mm LCP Mini-Fragment System (K090047) Device: Synthes Locking Hand Plates (K092247) Synthes Stainless Steel Modular Hand System (K030310) Synthes VA Locking Screws (K100776,… | 2009 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 4…Synthes 1.5mm LCP Mini-Fragment System (K090047) Device: Synthes Locking Hand Plates (K092247) Synthes Stainless Steel Modular Hand System (K030310) Synthes VA Locking Screws (K100776, K120689, K110354) Device The DePuy Synthes Variable Angle L… | 2003 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 4…e: Synthes Locking Hand Plates (K092247) Synthes Stainless Steel Modular Hand System (K030310) Synthes VA Locking Screws (K100776, K120689, K110354) Device The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates Descrip… | 2010 |
| * | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSummary page 4…Synthes Locking Hand Plates (K092247) Synthes Stainless Steel Modular Hand System (K030310) Synthes VA Locking Screws (K100776, K120689, K110354) Device The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates Description:… | 2012 |
| * | K110354 | 4.5MM VA-LCP Curved Condylar Plate SystemSummary page 4…es Locking Hand Plates (K092247) Synthes Stainless Steel Modular Hand System (K030310) Synthes VA Locking Screws (K100776, K120689, K110354) Device The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates Description: and scr… | 2011 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 22 of the 97 ancestors have a recall of any class.
- Of its descendants, K221150 (Double Medical Technology, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 17 other devices also cite its predicate K090047.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
Open reduction and internal fixation of fractures, mal-unions, and non-unions
Following excision of benign bone tumors
Replantations and reconstructions
Arthrodeses of joints involving small bones
Osteotomies, including deformity correction such as rotation, lengthening, shortening
Pathological fractures, including impending pathologic fractures
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141527: Depuy Synthes Variable Angle Locking Hand System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141527
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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