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 Nov 25, 2013 as substantially equivalent to K060478 (Arthrex, Inc., 2006) and 1 other predicate after a 131-day review. Its family tree reaches back 7 generations to 2000. 18 later devices descend from it.
- Decided
- Nov 25, 2013
- Review
- 131 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K000684 (2000). 30 ancestors in all, the oldest K890939 (1989). 18 later devices descend from it, 8 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- This deviceK132217 Arthrex Compression FT ScrewsArthrex, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK182361 Arthrex Compression FT ScrewsArthrex, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK162171 S4 Screw System™Subchondral Solutions · 2017
- Descendant · cites it directly · 3 of its ownK170382 Arthrex Compression ScrewsArthrex, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK191995 S4 Screw SystemSubchondral Solutions, Inc. · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015 · cites it directly6descendants
- K182361Arthrex Compression FT ScrewsArthrex, Inc. · 2018 · cites it directly4descendants
- K162171S4 Screw System™Subchondral Solutions · 2017 · cites it directly3descendants
- K170382Arthrex Compression ScrewsArthrex, Inc. · 2017 · cites it directly3descendants
- K191995S4 Screw SystemSubchondral Solutions, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K132217 | Arthrex Compression FT Screws | Arthrex, Inc. | 2013 | — |
| +1 | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| +1 | K182361 | Arthrex Compression FT Screws | Arthrex, Inc. | 2018 | — |
| +1 | K162171 | S4 Screw System™ | Subchondral Solutions | 2017 | — |
| +1 | K170382 | Arthrex Compression Screws | Arthrex, Inc. | 2017 | — |
| +2 | K191995 | S4 Screw System | Subchondral Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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.
What descends from it? (18)
See all 188 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150456 | Arthrex Plates, Screws, and Staples | 2015 | 6 |
| K182361 | Arthrex Compression FT Screws | 2018 | 4 |
| K162171 | S4 Screw System™ | 2017 | 3 |
| K170382 | Arthrex Compression Screws | 2017 | 3 |
| K250920 | Arthrex Spine Compression FT Screw | 2025 | 1 |
| K170038 | FuzeFix Screw System | 2017 | 1 |
| K220839 | Arthrex Compression FT Pins | 2022 | 0 |
| K170040 | BePOD Cannulated Arthrodesis Screws | 2017 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K150456 (Arthrex, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K060478.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Screw is intended for fixation of small bane 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) canceilous fragments (talus) Carpal, metacarpal, and small hand bone tarsal and metatarsals phalanges Intra-articular…
Read the full statement (94 words)
The Arthrex Compression Screw is intended for fixation of small bane 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)
canceilous 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
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 as stated in the FDA summary.
https://510kreport.com/device/K132217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132217: 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/K132217
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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