510(k) · Cleared
Recalled · Class II · 2018Wire & Steinman Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirschner Medical Corp. · HTY Pin, Fixation, Smooth
Cleared on May 18, 1983 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled 15 times.
- Decided
- May 18, 1983
- Review
- 49 days
- Class
- Class II
- Product code
- HTY
- Recalls
- 15
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK831005 Wire & Steinman PinsKirschner Medical Corp. · 1983
- Descendant · cites it directly · 7 of its ownK143618 Kirschner Wires, Steinmann PinsZimmer, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK241014 Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
1996high 3 (2026) · low 0 (1998)2026
Most influential descendants
Showing 5 of 10 · See all- K143618Kirschner Wires, Steinmann PinsZimmer, Inc. · 2015 · cites it directly7descendants
- K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024 · 2 generations on2descendants
- K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · 3 generations on1descendant
- K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. · 2016 · 2 generations on1descendant
- K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831005 | Wire & Steinman Pins | Kirschner Medical Corp. | 1983 | — |
| +1 | K143618 | Kirschner Wires, Steinmann Pins | Zimmer, Inc. | 2015 | — |
| +2 | K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024 | — |
| +3 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +2 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle… | Zimmer, Inc. | 2016 | — |
| +3 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2018 | Class II | Z-2242-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2241-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2240-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2238-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2234-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2235-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2236-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2239-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2237-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2230-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2233-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2231-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| May 16, 2018 | Class II | Z-2232-2018 | Under Investigation by firm | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging… |
| Aug 2, 2016 | Class II | Z-0087-2017 | Mixed-up of materials/components | The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball… |
| Apr 1, 2016 | Class II | Z-1822-2016 | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it… |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143618 (Zimmer, Inc., 2015) has gone furthest, with 7 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.
FDA decisions per year · HTY
5in 2025
2007high 9 (2010) · low 1 (2024)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
2007high 180 (2010) · low 73 (2014)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
2007high 2 (2016) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
2007high 297 (2024) · low 33 (2010)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 | — |
https://510kreport.com/device/K831005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K831005: Wire & Steinman Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026