510(k) · Cleared
ClearedREDEMPTION Beaming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, LLC · HWC Screw, Fixation, Bone
Cleared on Dec 13, 2022 as substantially equivalent to K014154 (Vilex, Inc., 2002) and 5 other predicates after a 218-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Dec 13, 2022
- Review
- 218 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K962616 (1996). 129 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 2 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 1 generation backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- This deviceK221342 REDEMPTION Beaming SystemVilex, LLC · 2022
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 5 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 4 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 3 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 2 generations backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- 1 generation backK203011 Monster Screw SystemParagon 28, Inc. · 2020
- This deviceK221342 REDEMPTION Beaming SystemVilex, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −5 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −4 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| −3 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| −2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| −1 | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
| 0 (this device) | K221342 | REDEMPTION Beaming System | Vilex, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 4…redicate Device Substantial equivalence is claimed to the following devices: • Primary Predicate o Vilex/Duval/Orthex Cannulated Bone Screw Double Thread, K014154, Vilex, Inc. • Additional Predicates o Vilex Bone Plate System, K041287, Vilex, Inc. o Mo… | 2002 |
| * | K041287 | Vilex Bone Plate SystemSummary page 4…o Vilex/Duval/Orthex Cannulated Bone Screw Double Thread, K014154, Vilex, Inc. • Additional Predicates o Vilex Bone Plate System, K041287, Vilex, Inc. o Monster Screw System™, K124027, K151418, K190586, & K203011, Paragon 28, Inc. The follo… | 2004 |
| * | K124027 | Monster Screw SystemSummary page 4…ble Thread, K014154, Vilex, Inc. • Additional Predicates o Vilex Bone Plate System, K041287, Vilex, Inc. o Monster Screw System™, K124027, K151418, K190586, & K203011, Paragon 28, Inc. The following devices are referenced in the submission: • FUZE… | 2013 |
| * | K151418 | Monster Screw SystemSummary page 4…d, K014154, Vilex, Inc. • Additional Predicates o Vilex Bone Plate System, K041287, Vilex, Inc. o Monster Screw System™, K124027, K151418, K190586, & K203011, Paragon 28, Inc. The following devices are referenced in the submission: • FUZE Intramedu… | 2015 |
| * | K190586 | Monster® Screw SystemSummary page 4…4, Vilex, Inc. • Additional Predicates o Vilex Bone Plate System, K041287, Vilex, Inc. o Monster Screw System™, K124027, K151418, K190586, & K203011, Paragon 28, Inc. The following devices are referenced in the submission: • FUZE Intramedullary Int… | 2019 |
| * | K203011 | Monster Screw SystemSummary page 4…Inc. • Additional Predicates o Vilex Bone Plate System, K041287, Vilex, Inc. o Monster Screw System™, K124027, K151418, K190586, & K203011, Paragon 28, Inc. The following devices are referenced in the submission: • FUZE Intramedullary Internal Fixat… | 2020 |
| † | K102413 | Fuze: Intramedullary Internal Fixation Nail | 2011 |
| † | K151881 | X-Fix Line Additions | 2016 |
| † | K191289 | Bone Screw Line Addition | 2019 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 129 ancestors have a recall of any class.
- 15 other devices also cite its predicate K014154.
How does its category compare?
All HWC devicesHWC Screw, 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 · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The REDEMPTION Beaming System is indicated for fracture fixation, osteotomies, reconstruction procedures, and fusions of bones in the foot and ankle including the Metatarsals, Cuneiforms, Cuboid, Navicular, Calcaneus and Talus. Specific examples include: Medial Column Fusion and Lateral Column Fusion resulting from neuropathic osteoarthropathy (Charcot).
The REDEMPTION Ø3.5mm Headless Screws are indicated for small bone fragments fracture and osteotomy in the lower extremities primarily the foot.
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/K221342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221342: REDEMPTION Beaming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221342
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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