510(k) · Cleared
ClearedArc Surgical Biotrak Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arc Surgical, LLC · HTY Pin, Fixation, Smooth
Cleared on Dec 19, 2007 as substantially equivalent to K041288 (Linvatec Biomaterials, Inc., 2004) and 3 other predicates after a 189-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Dec 19, 2007
- Review
- 189 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K864912 (1987). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK864912 PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc. · 1987
- 5 generations backK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
- 4 generations backK012000 1.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
- 3 generations backK013546 Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
- 2 generations backK031981 2.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003
- 1 generation backK041288 Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
- This deviceK071616 Arc Surgical Biotrak Pin SystemArc Surgical, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864912 | PDS (Polydioxanon) Absorbable Pin | Johnson & Johnson Professionals, Inc. | 1987 | — |
| −5 | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012000 | 1.5MM Bone Fixation Kit | Bionx Implants, Ltd. | 2001 | — |
| −3 | K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 | Bionx Implants, Inc. | 2001 | — |
| −2 | K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445 | Linvatec Biomaterials, Ltd. | 2003 | — |
| −1 | K041288 | Modification to Smartpin | Linvatec Biomaterials, Inc. | 2004 | — |
| 0 (this device) | K071616 | Arc Surgical Biotrak Pin System | Arc Surgical, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K041288 | Modification to SmartpinSummary page 1…egulatory Class: Class II, 21 CFR 888.3040 Device Product Code: HTY Legally Marketed Equivalent Device(s): Linvatec Biomaterials Ltd. SmartPin (K041288) Biomet, Inc. Resorbable Bone Pins (KO I1522)… | 2004 |
| * | K011522 | Resorbable Bone Pins | 2001 |
| * | K050259 | Arthrex Bio-PinSummary page 1…rtPin (K041288) Biomet, Inc. Resorbable Bone Pins (KO I1522) Arthrex, Inc. Bio-Pin (K050259) Arthrex, Inc. Chondral Dart (K991971) Device Description: The ARC Surgical BIOTRAKTM… | 2005 |
| * | K991971 | Arthrex Chondral Dart, Model AR-4005B-18Summary page 1…e Bone Pins (KO I1522) Arthrex, Inc. Bio-Pin (K050259) Arthrex, Inc. Chondral Dart (K991971) Device Description: The ARC Surgical BIOTRAKTM Pin System is composed of pins injection molded from poly-L-lactic acid (PLLA) w… | 2000 |
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 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 15 ancestors has a recall.
- 1 other device also cites its predicate K041288.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 BIOTIAKTM Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071616 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071616: Arc Surgical Biotrak Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071616
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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