510(k) · Cleared
ClearedArthrex Compression 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 May 11, 2017 as substantially equivalent to K132217 (Arthrex, Inc., 2013) after a 93-day review. Its family tree reaches back 8 generations to 2000. 3 later devices descend from it.
- Decided
- May 11, 2017
- Review
- 93 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000684 (2000). 31 ancestors in all, the oldest K890939 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 4 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 3 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 2 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 1 generation backK132217 Arthrex Compression FT ScrewsArthrex, Inc. · 2013
- This deviceK170382 Arthrex Compression ScrewsArthrex, Inc. · 2017
- 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
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −4 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −3 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −1 | K132217 | Arthrex Compression FT Screws | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K170382 | Arthrex Compression Screws | Arthrex, Inc. | 2017 | — |
| +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 | — |
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 |
|---|---|---|
| 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? (1)
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 Primary Predicate K132217: Arthrex Compression FT Screws Device Reference Predicate K123241: Arthrex Fracture Plates Device Purpose of This Sp… | 2013 |
| † | K123241 | Arthrex Fracture Plates | 2013 |
What descends from it? (3)
2 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 17 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 31 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. 2017, 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 Screws are intended for fixation of fractures, osteotomies and arthrodesis in:
• carpal, metacarpal and small hand bones
• 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
where size of offered implant is patient appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170382: Arthrex Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170382
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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