510(k) · Cleared
ClearedPCW Percutaneous Compression Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Medical Technologies, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 14, 2003 as substantially equivalent to K013888 (Miltex, Inc., 2002) after a 103-day review. Its family tree reaches back 1 generation to 2002. 314 later devices descend from it.
- Decided
- Jul 14, 2003
- Review
- 103 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K013888 (2002). 314 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- This deviceK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 310 of its ownK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- Descendant · 2 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
- Descendant · 3 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- Descendant · 3 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · 3 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
Showing 5 of 314 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 314 · See all- K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006 · cites it directly310descendants
- K103705Low Profile ScrewsArthrex, Inc. · 2011 · 2 generations on219descendants
- K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 3 generations on135descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 3 generations on91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 3 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| 0 (this device) | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| +1 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| +2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +3 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| +3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 20 | 0 |
| 2015 | 24 | 0 |
| 2016 | 7 | 0 |
| 2017 | 31 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 21 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 21 | 0 |
| 2024 | 24 | 0 |
| 2025 | 26 | 0 |
| 2026 | 37 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
What descends from it? (314)
See all 3142 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?
- Its one ancestor has no recall.
- Of its descendants, K062863 (Osteomed LP, 2006) has gone furthest, with 310 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Percutaneous Compression Wire system for the formation of osseous fragments or fractures of small bones, including:
Scaphoid fractures
Lunate fractures
Capitate
Carpal fractures & non-unions
Capitellum fractures
Humeral head fractures
Trapezial fractures
Metacarpal and metatarsal fractures
Phalangeal fractures
Distal radial fractures
Ulnar styloid fractures
Osteo-chrondral fractures
Small joint fusions
Glenoid fractures
Intercarpal fusions
Interphalangeal fractures
Metatarsal osteotomies
Tarsal fusions
Malleolar fractures
Hammer toe formation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031050: PCW Percutaneous Compression Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031050
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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