510(k) · Cleared
ClearedBiopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopro, Inc. · HTY Pin, Fixation, Smooth
Cleared on Mar 18, 2009 after a 113-day review. The FDA summary names no predicate by number. 10 later devices descend from it.
- Decided
- Mar 18, 2009
- Review
- 113 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK083490 Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685Biopro, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- Descendant · 2 generations on · 3 of its ownK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
- Descendant · 3 generations on · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · cites it directly8descendants
- K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · 2 generations on3descendants
- K150889Suture Wires and Wire LoopsZimmer, Inc. · 2015 · 2 generations on2descendants
- K203773BRM TOOL ScrewsBrm Extremities Srl · 2022 · 3 generations on1descendant
- K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685 | Biopro, Inc. | 2009 | — |
| +1 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| +2 | K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017 | 1 |
| +2 | K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015 | — |
| +3 | K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022 | — |
| +3 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle… | Zimmer, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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?
The FDA summary names no predicate by number.
What descends from it? (10)
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?
- Of its descendants, K110895 (Ortho Solutions Limited, 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The BioPro K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083490: Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083490
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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