510(k) · Cleared
ClearedTranset Fracture Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonutti Research, Inc. · HTY Pin, Fixation, Smooth
Cleared on Feb 25, 2004 as substantially equivalent to K990156 (Bonutti Research, 1999) and 3 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1990. 309 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 91 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K904436 (1990). 17 ancestors in all, the oldest K901456 (1990). 309 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 2 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 1 generation backK990156 Multitak SS ButtonsBonutti Research · 1999
- This deviceK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
- Descendant · cites it directly · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 2 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · 2 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- Descendant · 2 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 309 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 309 · See all- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · cites it directly306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 2 generations on217descendants
- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 2 generations on94descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 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 |
|---|---|---|---|---|---|
| −4 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −3 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −2 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −1 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| 0 (this device) | K033717 | Transet Fracture Fixation System | Bonutti Research, Inc. | 2004 | — |
| +1 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +2 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +2 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| +2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 18 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 15 | 0 |
| 2018 | 15 | 0 |
| 2019 | 26 | 0 |
| 2020 | 22 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 26 | 0 |
| 2024 | 35 | 0 |
| 2025 | 30 | 0 |
| 2026 | 34 | 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? (4)
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 |
|---|---|---|---|
| * | K990156 | Multitak SS ButtonsSummary page 2…redicate Device (s): The TranSet M T Fracture Fixation System is similar in intended use and materials to the Multitak SS Buttons (K990156), Linvatec, Corp., BioButtonT M (K990194) and Inion, Ltd., OTPSTM Biodegradable pins (K031712). The TranSetT M Fracture Fixation… | 1999 |
| * | K990194 | BiobuttonSummary page 2…Fracture Fixation System is similar in intended use and materials to the Multitak SS Buttons (K990156), Linvatec, Corp., BioButtonT M (K990194) and Inion, Ltd., OTPSTM Biodegradable pins (K031712). The TranSetT M Fracture Fixation System buttons are also similar in design… | 1999 |
| * | K031712 | Inion Otps Biodegradable PinSummary page 2…System is similar in intended use and materials to the Multitak SS Buttons (K990156), Linvatec, Corp., BioButtonT M (K990194) and Inion, Ltd., OTPSTM Biodegradable pins (K031712). The TranSetT M Fracture Fixation System buttons are also similar in design and materials to the Multitakl SS Buttons and the Mu… | 2003 |
| * | K012465 | Multitak Splinter 3.0 MM Resorbable Anchor Our reading of the summary gave K012456, FDA’s number for Sodem High Speed System (Electric) (Ear, Nose, and Throat) (Sodemsystems). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Multitak Splinter 3.0 mm Resorbable Anchors”. | 2001 |
What descends from it? (309)
See all 3092 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K043248 (Arthrex, Inc., 2005) has gone furthest, with 306 descendants of its own.
- 1 other device also cites its predicate K990156.
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
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 TranSet Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with…
Read the full statement (160 words)
The TranSet Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet Fracture Fixation System. The TranSet Fracture Fixation System is not indicated for use in intra-articular sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033717 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033717: Transet Fracture Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033717
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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