510(k) · Cleared
ClearedTyber Medical Pin and Wire System (various)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · HTY Pin, Fixation, Smooth
Cleared on Jul 6, 2023 as substantially equivalent to K083490 (Biopro, Inc., 2009) and 1 other predicate after a 59-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jul 6, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961522 (1996). 5 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 deviceK231339 Tyber Medical Pin and Wire System (various)Tyber Medical, LLC · 2023
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) | K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685Summary page 4…ber 888.3040 Product Code HTY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K083490 BioPro K-Wire HTY K100736 SMT Schilling Metalltechnik GmbH HTY Device Description Summary 21 CFR 807.92(a)(4) The Tyber Medical… | 2009 |
| * | K100736 | Kirschner and Guide WiresSummary page 4…HTY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K083490 BioPro K-Wire HTY K100736 SMT Schilling Metalltechnik GmbH HTY Device Description Summary 21 CFR 807.92(a)(4) The Tyber Medical Pin and Wire System is des… | 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 27 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K083490.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fractures (e.g., small bone fragment(s) of hand or foot), 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231339: Tyber Medical Pin and Wire System (various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231339
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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