510(k) · Cleared
ClearedArthrosurface Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 22, 2017 as substantially equivalent to K143614 (Arthrex, Inc., 2015) and 4 other predicates after a 136-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Dec 22, 2017
- Review
- 136 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K962616 (1996). 156 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK122334 Checkmate Small Bone Fusion SystemArthrosurface, Inc. · 2012
- 2 generations backK140617 Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
- 1 generation backK161539 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2016
- This deviceK172383 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK200226 RetroFixRetrofix Screws, LLC · 2020
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK122334 Checkmate Small Bone Fusion SystemArthrosurface, Inc. · 2012
- 2 generations backK140617 Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
- 1 generation backK161539 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2016
- This deviceK172383 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K200226RetroFixRetrofix Screws, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K122334 | Checkmate Small Bone Fusion System | Arthrosurface, Inc. | 2012 | — |
| −2 | K140617 | Pinit Small Bone Fusion System | Arthrosurface, Inc. | 2014 | — |
| −1 | K161539 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2016 | — |
| 0 (this device) | K172383 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2017 | — |
| +1 | K200226 | RetroFix | Retrofix Screws, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 16 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K143614 | Arthrex Low Profile ScrewsSummary page 5…to the following previously cleared and commercially marketed predicate devices: Primary Predicate(s) x Arthrex Low Profile Screws K143614 Additional Predicate(s) x Arthrex Fracture System K112437 x Arthrex Low Profile Screw… | 2015 |
| * | K112437 | Arthrex Fracture SystemSummary page 5…e(s) x Arthrex Low Profile Screws K143614 Additional Predicate(s) x Arthrex Fracture System K112437 x Arthrex Low Profile Screws K103705 x Synthes Cortical Screws… | 2011 |
| * | K103705 | Low Profile ScrewsSummary page 5…3614 Additional Predicate(s) x Arthrex Fracture System K112437 x Arthrex Low Profile Screws K103705 x Synthes Cortical Screws K112583 x Arthrosurface Bone Screws… | 2011 |
| * | K112583 | Synthes Cortical ScrewsSummary page 5…K112437 x Arthrex Low Profile Screws K103705 x Synthes Cortical Screws K112583 x Arthrosurface Bone Screws K161539 The fundamental scientific technology of the proposed… | 2011 |
| * | K161539 | Arthrosurface Bone ScrewsSummary page 5…K103705 x Synthes Cortical Screws K112583 x Arthrosurface Bone Screws K161539 The fundamental scientific technology of the proposed device has not changed relative to the predicate devices: x Has sim… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200226 | RetroFix | 2020 | 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 21 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 24 of the 156 ancestors have a recall of any class.
- Of its descendants, K200226 (Retrofix Screws, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K143614.
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 Arthrosurface Bone Screws (2.0-3.0 mm solid and 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 Arthrosurface Bone Screws (3.5 mm and larger, solid and 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, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172383: Arthrosurface Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172383
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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