510(k) · Cleared
ClearedField Orthopaedics Micro Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Field Orthopaedics Pty, Ltd. · HWC Screw, Fixation, Bone
Cleared on Jul 17, 2018 as substantially equivalent to K051567 (Medartis, Inc., 2005) and 1 other predicate after a 159-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Jul 17, 2018
- Review
- 159 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962616 (1996). 19 ancestors in all, the oldest K885250 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 3 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 2 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 1 generation backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- This deviceK180348 Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK200043 Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range…Field Orthopaedics Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK241695 Extremity All Suture SystemField Orthopaedics · 2024
- Descendant · 2 generations on · 0 of its ownK230118 Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd. · 2020 · cites it directly1descendant
- K241695Extremity All Suture SystemField Orthopaedics · 2024 · cites it directly0descendants
- K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −4 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −3 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −2 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −1 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| 0 (this device) | K180348 | Field Orthopaedics Micro Screw System | Field Orthopaedics Pty, Ltd. | 2018 | — |
| +1 | K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate… | Field Orthopaedics Pty, Ltd. | 2020 | — |
| +1 | K241695 | Extremity All Suture System | Field Orthopaedics | 2024 | — |
| +2 | K230118 | Bony Trauma Extremity System (BTES) Screw Range, NX Nail | Field Orthopaedics Pty, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K051567 | Aptus Titanium Osteosynthesis SystemSummary page 4…I Classification Panel: Orthopaedic Regulation Number: 21 CFR section 888.3040 C. PREDICATE AND REFERENCE DEVICES C1: Primary Predicates Devices: K051567 Medartis, Inc Aptus 1.2 Cortical Screw APTUS Titanium Fixation System A… | 2005 |
| * | K100736 | Kirschner and Guide WiresSummary page 4…dicates Devices: K051567 Medartis, Inc Aptus 1.2 Cortical Screw APTUS Titanium Fixation System Aptus 1.2 Hand K100736 SMT Schilling 0.6 - 2.0 mm Single and Double Orthopaedic Fixation Pins and Metailtechnik GmbH Tr… | 2010 |
| † | K121425 | Ortholoc 3DI Ankle Fusion Plating System | 2012 |
| † | K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws | 2014 |
| † | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | 2005 |
| † | K124027 | Monster Screw System | 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 22 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K200043 (Field Orthopaedics Pty, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 21 other devices also cite its predicate K051567.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Field Orthopaedics Micro Screw System consists of the following kits with the following indications:
The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.
The FO Pin and Wire Kit is intended for fixation and stabilization of bone fractures or as guidance at insertion of implants into the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180348: Field Orthopaedics Micro Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180348
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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