510(k) · Cleared
ClearedDepuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone
Cleared on Mar 23, 2015 as substantially equivalent to K030310 (Synthes (Usa), 2003) and 3 other predicates after a 62-day review. Its family tree reaches back 11 generations to 1996. 14 later devices descend from it.
- Decided
- Mar 23, 2015
- Review
- 62 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K962616 (1996). 86 ancestors in all, the oldest K792022 (1979). 14 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- Descendant · cites it directly · 4 of its ownK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024
- Descendant · cites it directly · 3 of its ownK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK221558 ALPHALOK Plating SystemVilex, LLC · 2022
- Descendant · cites it directly · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK253906 Xpert HandNewclip Technics · 2026
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes · 2024 · cites it directly4descendants
- K212348ALPHALOK™ Plating SystemVilex, LLC · 2022 · cites it directly3descendants
- K221558ALPHALOK Plating SystemVilex, LLC · 2022 · 2 generations on2descendants
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · cites it directly1descendant
- K253906Xpert HandNewclip Technics · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | 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 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| 0 (this device) | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and… | Synthes (USA) Products, LLC | 2015 | — |
| +1 | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small… | DePuy Synthes | 2024 | — |
| +1 | K212348 | ALPHALOK™ Plating System | Vilex, LLC | 2022 | — |
| +2 | K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 | — |
| +1 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
| +1 | K253906 | Xpert Hand | Newclip Technics | 2026 | — |
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 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 4…and Screws) Classification: Class II, HRS, §888.3030 – Plate, Fixation, Bone Class II, HWC, §888.3040 – Screw, Fixation, Bone Primary K030310 – Synthes Stainless Steel Modular Hand System Predicate Devices Additional K063049 – Synthes (USA) Modular Mini Fragmen… | 2003 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 4…Class II, HWC, §888.3040 – Screw, Fixation, Bone Primary K030310 – Synthes Stainless Steel Modular Hand System Predicate Devices Additional K063049 – Synthes (USA) Modular Mini Fragment LCP System Predicate K100776 – Synthes 2.4 mm/2.7 mm Variable Angle LCP Forefoot/M… | 2006 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 4…K030310 – Synthes Stainless Steel Modular Hand System Predicate Devices Additional K063049 – Synthes (USA) Modular Mini Fragment LCP System Predicate K100776 – Synthes 2.4 mm/2.7 mm Variable Angle LCP Forefoot/Midfoot System Devices K112583 - Synthes Cortical Screws… | 2010 |
| * | K112583 | Synthes Cortical ScrewsSummary page 4…K063049 – Synthes (USA) Modular Mini Fragment LCP System Predicate K100776 – Synthes 2.4 mm/2.7 mm Variable Angle LCP Forefoot/Midfoot System Devices K112583 - Synthes Cortical Screws The DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Device… | 2011 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment… | 2024 | 4 |
| K212348 | ALPHALOK™ Plating System | 2022 | 3 |
| K190391 | TDM Plate and Screw Systems | 2019 | 1 |
| K253906 | Xpert Hand | 2026 | 0 |
| K241815 | Protean Fragment Plating System | 2024 | 0 |
| K200575 | Truemed Hand, Foot and Ankle Plates System | 2021 | 0 |
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 1.6 years on median.
- 18 of the 86 ancestors have a recall of any class.
- Of its descendants, K233665 (DePuy Synthes, 2024) has gone furthest, with 4 descendants of its own.
- 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. 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:
o Open reduction and internal fixation of fractures, mal-unions, and non-unions
o Following excision of benign bone tumors
o Replantations and reconstructions
o Arthrodeses of joints involving small bones
o Osteotomies, including deformity correction such as rotation, lengthening, shortening
o Pathological fractures, including impending pathologic fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150099
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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