510(k) · Cleared
ClearedPacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Instruments · HTY Pin, Fixation, Smooth
Cleared on Feb 17, 2022 as substantially equivalent to K100736 (Smt Schilling Metalltechnik GmbH, 2010) after a 59-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 17, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961522 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 2 generations backK030665 Bone WireStork Instrumente GmbH · 2003
- 1 generation backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- This deviceK213982 Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner /…Pacific Instruments · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −2 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| −1 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| 0 (this device) | K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K100736 | Kirschner and Guide WiresSummary page 4…or Manufacturer Predicate Model Name Type K100736 Orthopaedic Fixation Pins and SMT Shilling Primary… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- 11 other devices also cite its predicate K100736.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of instruments and implants into the skeletal system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213982 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213982: Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213982
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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