510(k) · Cleared
ClearedALPHALOK™ Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, LLC · HRS Plate, Fixation, Bone
Cleared on May 2, 2022 as substantially equivalent to K041287 (Vilex, Inc., 2004) and 2 other predicates after a 278-day review. Its family tree reaches back 12 generations to 1996. 3 later devices descend from it.
- Decided
- May 2, 2022
- Review
- 278 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K962616 (1996). 97 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- This deviceK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
- Descendant · cites it directly · 2 of its ownK221558 ALPHALOK Plating SystemVilex, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK233816 REDEMPTION Charcot Plating SystemVilex, LLC · 2024
- Descendant · cites it directly · 0 of its ownK230204 ALPHALOK Plating SystemVilex, LLC · 2023
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- This deviceK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
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 |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −1 | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and… | Synthes (USA) Products, LLC | 2015 | — |
| 0 (this device) | K212348 | ALPHALOK™ Plating System | Vilex, LLC | 2022 | — |
| +1 | K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 | — |
| +2 | K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024 | — |
| +1 | K230204 | ALPHALOK Plating System | Vilex, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K041287 | Vilex Bone Plate SystemSummary page 4…sification II III. Predicate Device Substantial equivalence is claimed to the following devices: • Primary Predicate: o Vilex Bone Plate Systems, K041287, Vilex, Inc. • Additional Predicates o DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates… | 2004 |
| * | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Summary page 4…tems, K041287, Vilex, Inc. • Additional Predicates o DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), K150099, DePuy Synthes o ARIX Hand System, K131566, Jeil Medical Corporation… | 2015 |
| * | K131566 | Arix Hand SystemSummary page 4…o DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), K150099, DePuy Synthes o ARIX Hand System, K131566, Jeil Medical Corporation Page 1 of 3 ===… | 2013 |
What descends from it? (3)
2 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 26 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 21 of the 97 ancestors have a recall of any class.
- Of its descendants, K221558 (Vilex, LLC, 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K041287.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212348: ALPHALOK™ Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212348
Report an extraction error
Are you the manufacturer?
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