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 Apr 25, 2023 as substantially equivalent to K163044 (Wrightmedicaltechnologyinc, 2017) and 2 other predicates after a 90-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Apr 25, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K962616 (1996). 107 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- 2 generations backK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
- 1 generation backK221558 ALPHALOK Plating SystemVilex, LLC · 2022
- This deviceK230204 ALPHALOK Plating SystemVilex, LLC · 2023
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 3 generations backK150099 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm…Synthes (USA) Products, LLC · 2015
- 2 generations backK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
- 1 generation backK221558 ALPHALOK Plating SystemVilex, LLC · 2022
- This deviceK230204 ALPHALOK Plating SystemVilex, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −3 | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and… | Synthes (USA) Products, LLC | 2015 | — |
| −2 | K212348 | ALPHALOK™ Plating System | Vilex, LLC | 2022 | — |
| −1 | K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 | — |
| 0 (this device) | 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 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating SystemSummary page 6…II. Predicate Device Substantial equivalence is claimed to the following devices: • Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044) - (Primary Predicate) • Vilex ALPHALOK™ Plating System (K221558, K212348) - (Additional Predicate… | 2017 |
| * | K221558 | ALPHALOK Plating SystemSummary page 6…es: • Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044) - (Primary Predicate) • Vilex ALPHALOK™ Plating System (K221558, K212348) - (Additional Predicate) IV. Device Description The ALPHALOK™ Plating System is a multi-indication… | 2022 |
| * | K212348 | ALPHALOK™ Plating SystemSummary page 6…• Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044) - (Primary Predicate) • Vilex ALPHALOK™ Plating System (K221558, K212348) - (Additional Predicate) IV. Device Description The ALPHALOK™ Plating System is a multi-indication reconstru… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 107 ancestors have a recall of any class.
- 6 other devices also cite its predicate K163044.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ALPHALOKT™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: » Forefoot, Midfoot, and Hindfoot Osteotomies * Metatarsals and Metacarpals Corrections and Osteotomies » Stabilization and Fixation of Metatarsal and Metacarpal Fractures »…
Read the full statement (177 words)
The ALPHALOKT™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include:
» Forefoot, Midfoot, and Hindfoot Osteotomies
* Metatarsals and Metacarpals Corrections and Osteotomies
» Stabilization and Fixation of Metatarsal and Metacarpal Fractures
» Stabilization and Fixation of Ankle Fractures
» Syndesmosis Joint Stabilization
* Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
* Flatfoot and Cavus Foot Corrections
* Charcot Fixation
The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
» Lateral Malleolar Fractures
» Syndesmosis Injuries
» Medial Malleolar Fractures
» Bi-Malleolar Fractures
» Tri-Malleolar Fractures
» Posterior Malleolar Fractures
» Distal Anterior Tibia Fractures
» Vertical Shear Fractures of the Medial Malleolus
» Pilon Fractures
* Distal Tibia Shaft Fractures
» Distal Fibula Shaft Fractures
» Distal Tibia Periarticular Fractures
» Medial Malleolar Avulsion Fractures
» Lateral Malleolar Avulsion 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/K230204 · printed Nov 3, 2026
Cite this page
510(k) Report. “K230204: ALPHALOK Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K230204
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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