510(k) · Cleared
ClearedArthrex Compression FT Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 18, 2018 as substantially equivalent to K132217 (Arthrex, Inc., 2013) and 1 other predicate after a 110-day review. Its family tree reaches back 11 generations to 2000. 4 later devices descend from it.
- Decided
- Dec 18, 2018
- Review
- 110 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K000684 (2000). 78 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations between
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- This deviceK182361 Arthrex Compression FT ScrewsArthrex, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK221090 Metal Cannulated ScrewDouble Medical Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK220839 Arthrex Compression FT PinsArthrex, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 9 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 8 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 7 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 6 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 5 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 4 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- This deviceK182361 Arthrex Compression FT ScrewsArthrex, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · cites it directly1descendant
- K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026 · 2 generations on0descendants
- K221090Metal Cannulated ScrewDouble Medical Technology, Inc. · 2023 · cites it directly0descendants
- K220839Arthrex Compression FT PinsArthrex, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −10 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −9 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −8 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −7 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −6 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −5 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −4 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −2 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −1 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| 0 (this device) | K182361 | Arthrex Compression FT Screws | Arthrex, Inc. | 2018 | — |
| +1 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +2 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026 | — |
| +1 | K221090 | Metal Cannulated Screw | Double Medical Technology, Inc. | 2023 | — |
| +1 | K220839 | Arthrex Compression FT Pins | Arthrex, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 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 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K132217 | Arthrex Compression FT ScrewsSummary page 4…, bone Product Code HWC Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K132217: Arthrex Compression FT Screws K141735: Arthrex Ankle Fusion Plating System Purpose of This Spec… | 2013 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 4…888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K132217: Arthrex Compression FT Screws K141735: Arthrex Ankle Fusion Plating System Purpose of This Special 510(k) premarket notification is submitted to obtain clea… | 2014 |
What descends from it? (4)
3 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 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 78 ancestors have a recall of any class.
- Of its descendants, K250920 (Arthrex, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K132217.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Arthrex Compression FT Screws are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Osteochondral fragments (talar vault, femoral condyle) apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal) cancellous fragments (talus) Carpal, metacarpal, and small hand bone tarsal and metatarsals phalanges Intra-articular…
Read the full statement (95 words)
The Arthrex Compression FT Screws are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
Osteochondral fragments (talar vault, femoral condyle)
apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
cancellous fragments (talus)
Carpal, metacarpal, and small hand bone
tarsal and metatarsals
phalanges
Intra-articular fractures
ankle
proximal and distal humerus
proximal and distal radius
proximal and distal ulna
osteocondral fixation and fractures
Osteochondritis Dissecans
Fixation of fractures and osteotomies about the knee
Oblique fractures of the fibula
Reconstructive surgeries of the foot
malleolar fixation
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/K182361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182361: Arthrex Compression FT Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182361
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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