510(k) · Cleared
Recalled · Class II · 2022HammerTube System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28 · HTY Pin, Fixation, Smooth
Cleared on Mar 5, 2018 as substantially equivalent to K131459 (Aap Implantate AG, 2013) after a 269-day review. Its family tree reaches back 4 generations to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 5, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- HTY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961522 (1996). 5 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 3 generations backK030665 Bone WireStork Instrumente GmbH · 2003
- 2 generations backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- 1 generation backK131459 Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013
- This deviceK171715 HammerTube SystemParagon 28 · 2018
- Descendant · cites it directly · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK262722 Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241262 Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223184 Phantom Metatarsal Shortening SystemParagon 28, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK202777 VeriFixx™ Small Bone ImplantArmis Biopharma, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · cites it directly1descendant
- K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026 · cites it directly0descendants
- K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024 · 2 generations on0descendants
- K223184Phantom Metatarsal Shortening SystemParagon 28, Inc. · 2022 · cites it directly0descendants
- K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −3 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| −2 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| −1 | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | Aap Implantate AG | 2013 | — |
| 0 (this device) | K171715 | HammerTube System | Paragon 28 | 2018 | — |
| +1 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +1 | K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026 | — |
| +2 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024 | — |
| +1 | K223184 | Phantom Metatarsal Shortening System | Paragon 28, Inc. | 2022 | — |
| +1 | K202777 | VeriFixx™ Small Bone Implant | Armis Biopharma, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K131459 | Aap K-Wire, Steinmann Pin, Cerclage WireSummary page 5…m plasma spray coating as described by ASTM F1580 or from stainless steel per ASTM F138. Primary Predicate: aap Wire Bone (aap Implante AG – K131459) Reference Device: Tyber Medical Wedge System (Tyber Medical LLC – K150394) Performance Data: Static and dynamic cant… | 2013 |
| † | K150394 | Tyber Medical Wedge System | 2015 |
What descends from it? (6)
5 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 26, 2022 | Class II | Z-1468-2022 | Under Investigation by firm | Due to Titanium plasma coating not present implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K231231 (Paragon 28, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K131459.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-wires for delivery of implants or for the temporary…
Read the full statement (128 words)
The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures.
The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint.
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerTube™ System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171715: HammerTube System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171715
Report an extraction error
Are you the manufacturer?
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