510(k) · Cleared
ClearedCannulated Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxion Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Aug 3, 2022 as substantially equivalent to K201132 (Arthrex, Inc., 2020) and 1 other predicate after a 261-day review. Its family tree reaches back 13 generations to 2000.
- Decided
- Aug 3, 2022
- Review
- 261 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K000684 (2000). 129 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 9 generations between
- 3 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 2 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 1 generation backK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- This deviceK213614 Cannulated ScrewsMaxxion Medical, LLC · 2022
Show all 13 generations
- Root · 13 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 12 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 11 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 10 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 9 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 8 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 7 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 6 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 5 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 4 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 3 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 2 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 1 generation backK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- This deviceK213614 Cannulated ScrewsMaxxion Medical, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −12 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −11 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −10 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −9 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −8 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −7 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −6 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −5 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −4 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −3 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −2 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| −1 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K213614 | Cannulated Screws | Maxxion Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 15 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 10 | 0 |
| 2000 | 4 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 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? (2)
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 |
|---|---|---|---|
| * | K201132 | Arthrex Compression ScrewsSummary page 5…sories; Class II. III. Predicate Devices: Legally marketed devices to which we are claiming “Substantial Equivalence” are the following: Arthrex Compression FT Screws (K201132) (Primary predicate device). APTUS® Cannulated Compression Screw and APTUS® Headed Cannulated Compression Screw (K202589) (Additi… | 2020 |
| * | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Summary page 5…re the following: Arthrex Compression FT Screws (K201132) (Primary predicate device). APTUS® Cannulated Compression Screw and APTUS® Headed Cannulated Compression Screw (K202589) (Additional predicate device). IV. Device Description: Cannulated Screws are implantable medical devices developed for applica… | 2020 |
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 22 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 129 ancestors have a recall of any class.
- 7 other devices also cite its predicate K201132.
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?
Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, osteotomies, and arthrodesis of bones with the appropriate screw size. The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. The Cannulated Compression Taper Screw (3.5 mm and…
Read the full statement (106 words)
Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, osteotomies, and arthrodesis of bones with the appropriate screw size.
The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213614: Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213614
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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