510(k) · Cleared
ClearedLow Profile 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 Mar 18, 2011 as substantially equivalent to K052614 (Arthrex, Inc., 2005) and 4 other predicates after an 88-day review. Its family tree reaches back 6 generations to 2000. 219 later devices descend from it.
- Decided
- Mar 18, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K000684 (2000). 28 ancestors in all, the oldest K890939 (1989). 219 later devices descend from it, 22 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 2 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 1 generation backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- This deviceK103705 Low Profile ScrewsArthrex, Inc. · 2011
- Descendant · cites it directly · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- Descendant · cites it directly · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · cites it directly · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- Descendant · 2 generations on · 38 of its ownK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
Showing 5 of 219 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 219 · See all- K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · cites it directly135descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · cites it directly91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · cites it directly71descendants
- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
- K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · 2 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −2 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −1 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +1 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| +1 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +1 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +1 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| +2 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
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 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 12 | 0 |
| 2016 | 2 | 0 |
| 2017 | 23 | 0 |
| 2018 | 8 | 0 |
| 2019 | 13 | 0 |
| 2020 | 19 | 0 |
| 2021 | 16 | 0 |
| 2022 | 15 | 0 |
| 2023 | 19 | 0 |
| 2024 | 22 | 0 |
| 2025 | 21 | 0 |
| 2026 | 30 | 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 |
|---|---|---|---|
| * | K052614 | Low Profile Plate and Screw SystemSummary page 1…21 CER 888.3040: Smooth or threaded metallic bone fixation fastener. Predicate Device K052614: Arthrex Low Profile Plate and Screw System K062863: Osteoined Extended 2.0/2 .4… | 2005 |
| * | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw SystemSummary page 1…fastener. Predicate Device K052614: Arthrex Low Profile Plate and Screw System K062863: Osteoined Extended 2.0/2 .4 Cannulated Screw System K001941: Synthes Modular Fo… | 2006 |
| * | K001941 | Synthes Modular Foot SystemSummary page 1…rew System K062863: Osteoined Extended 2.0/2 .4 Cannulated Screw System K001941: Synthes Modular Foot System K043185: Synthes 3.5mm Cortex Screws… | 2000 |
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 1…d 2.0/2 .4 Cannulated Screw System K001941: Synthes Modular Foot System K043185: Synthes 3.5mm Cortex Screws K102343: Cannulated Screw System Purpo… | 2005 |
| * | K102343 | Emerge Medical Cannulated Screw Fixation SystemSummary page 1…01941: Synthes Modular Foot System K043185: Synthes 3.5mm Cortex Screws K102343: Cannulated Screw System Purpose Of Submission This traditional 510(k) premarket notification is submitted to… | 2010 |
What descends from it? (219)
See all 21922 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111253 | Arthrex Distal Extremity Plate System | 2011 | 135 |
| K112437 | Arthrex Fracture System | 2011 | 91 |
| K123241 | Arthrex Fracture Plates | 2013 | 71 |
| K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | 2012 | 58 |
| K140397 | Paralock Plating System / Tuffnek Screw | 2014 | 31 |
| K141478 | Arthrex Fracture Plates and Screws | 2014 | 23 |
| K131474 | Arthrex Distal Radius Plate System | 2013 | 20 |
| K143614 | Arthrex Low Profile Screws | 2015 | 19 |
| K132217 | Arthrex Compression FT Screws | 2013 | 18 |
| K131061 | Restore Bunion Correction System | 2013 | 15 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K111253 (Arthrex, Inc., 2011) has gone furthest, with 135 descendants of its own.
- 12 other devices also cite its predicate K052614.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates. The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for…
Read the full statement (214 words)
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates.
The Arthrex Low Profile Screws (2.0-3.0mm 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 Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, 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, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103705: Low Profile Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103705
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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