510(k) · Cleared
ClearedArthrex Compression FT Pins
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 Sep 19, 2022 as substantially equivalent to K132217 (Arthrex, Inc., 2013) and 1 other predicate after a 180-day review. Its family tree reaches back 12 generations to 2000.
- Decided
- Sep 19, 2022
- Review
- 180 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K000684 (2000). 79 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations between
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- 1 generation backK182361 Arthrex Compression FT ScrewsArthrex, Inc. · 2018
- This deviceK220839 Arthrex Compression FT PinsArthrex, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 11 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 10 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 9 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 8 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 7 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 6 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 5 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 4 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- 1 generation backK182361 Arthrex Compression FT ScrewsArthrex, Inc. · 2018
- This deviceK220839 Arthrex Compression FT PinsArthrex, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −11 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −10 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −9 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −8 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −7 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −6 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −5 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −4 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −2 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| −1 | K182361 | Arthrex Compression FT Screws | Arthrex, Inc. | 2018 | — |
| 0 (this device) | 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 |
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…uct Code HWC Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fastener Regulatory Class II Primary Predicate Device K132217: Arthrex Compression FT Screws Additional Predicate K182361: Arthrex Compression FT Screws Devices Reference Devices… | 2013 |
| * | K182361 | Arthrex Compression FT ScrewsSummary page 4…040: Smooth or threaded metallic bone fastener Regulatory Class II Primary Predicate Device K132217: Arthrex Compression FT Screws Additional Predicate K182361: Arthrex Compression FT Screws Devices Reference Devices K201132: Arthrex Compression Screws… | 2018 |
| † | K201132 | Arthrex Compression Screws | 2020 |
| † | K210994 | Arthrex Beveled FT Screws | 2021 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 79 ancestors have a recall of any class.
- 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. 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 Arthrex Compression FT pins (1.9 mm) are intended for small bone fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee. The Arthrex Compression FT pins (2.4 mm) are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: * Osteochondral fragments * Apical fragments (radial head, patellar rim, navicular…
Read the full statement (133 words)
The Arthrex Compression FT pins (1.9 mm) are intended for small bone fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee.
The Arthrex Compression FT pins (2.4 mm) are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
* Osteochondral fragments
* Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
* Cancellous fragments
* 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
» Osteochondral 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/K220839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220839: Arthrex Compression FT Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220839
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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