510(k) Report

510(k) · Cleared

Cleared

Intraosseous Fixation System

K120165510(k) TraditionalCleared Apr 17, 201289-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Orthohelix Surgical Designs, Inc. · HTY Pin, Fixation, Smooth

Cleared on Apr 17, 2012 as substantially equivalent to K022599 (New Deal, S.A., 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1996. 35 later devices descend from it.

Decided
Apr 17, 2012
Review
89 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K960385 (1996). 5 ancestors in all. 35 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor2014: 2 descendants cleared2017: 2 descendants cleared2015: 4 descendants cleared2020: 2 descendants cleared2016: 2 descendants cleared2019: 5 descendants cleared2018: 1 descendant cleared2021: 3 descendants cleared2023: 3 descendants cleared2024: 4 descendants cleared2025: 3 descendants cleared2026: 4 descendants clearedK960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 1996K022599 · Newdeal K Wire · New Deal, S.A. · 2002K070598 · Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse · Memometal Technologies · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 6 descendants4 generations forward: 7 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants K070598 · Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse · Memometal Technologies · 2007K022599 · Newdeal K Wire · New Deal, S.A. · 2002K960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 19960+5
  1. Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. 1 generation backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  4. This deviceK120165 Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012
  5. Descendant · cites it directly · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
  6. Descendant · cites it directly · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  7. Descendant · 2 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
  8. Descendant · 3 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
  9. Descendant · 4 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2014: 22015: 42016: 22017: 22018: 12019: 52020: 22021: 32023: 32024: 42025: 32026: 4
2014high 5 (2019) · low 0 (2022)2026

Most influential descendants

Showing 5 of 35 · See all
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · cites it directly31descendants
  • K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly16descendants
  • K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 2 generations on15descendants
  • K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 3 generations on14descendants
  • K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
−2K022599Newdeal K WireNew Deal, S.A.2002—
−1K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies2007—
0 (this device)K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.2012—
+1K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—
+1K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+2K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC2015—
+3K181872MIS Bunion SystemCrossroads Extremity Systems, LLC2019—
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201540
201620
201720
201810
201950
202020
202130
202330
202440
202530
202640
FIG. 1 — Lineage of K120165, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K022599Newdeal K Wire
Summary page 1
…teotomies of the phalanges. Substantial Equivalence: The lntraosseous Fixation System is substantially equivalent to the New Deal K-wire (K(022599) and Memometal Technologies Smart Toe (K(070598). Mechanical 4 point bend testing was performed to…
New Deal, S.A.2002—
*K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
Summary page 1
…xation System is substantially equivalent to the New Deal K-wire (K(022599) and Memometal Technologies Smart Toe (K(070598). Mechanical 4 point bend testing was performed to establish substantial equivalence. No new issues of…
Memometal Technologies2007—

Also cleared against K022599: 22 other devices →

What descends from it? (35)

See all 35

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431
K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516
K170326dynaMX Intramedullary ImplantArthrex, Inc.20172
K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140

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 16 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K133636 (Extremity Medical, LLC, 2014) has gone furthest, with 31 descendants of its own.
  • 22 other devices also cite its predicate K022599.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

The lntraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

Indications for use as stated in the FDA summary.

Also cleared against K022599

22 other devices cite the same predicate.

  • K203698CoLink Sfx Implant SystemIn2bones USA, LLC · 2021
  • K153770OS2(R)-VP Varisation StapleIn2bones Sas · 2016
  • K153204In2Bones Kirschner wireIn2bones Sas · 2016
  • K150211EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015
  • K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics · 2015
  • K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015

More from Orthohelix Surgical Designs, Inc.

25 FDA decisions under this applicant name. See the company

  • K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2014
  • K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014
  • K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014
  • K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc. · 2014
  • K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013

Recent decisions in HTY

The HTY category page

  • K262126Cerclage Wires;K-wires;Steinmann PinsMK Medical GmbH · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions · 2025
  • K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
  • K250315Ronavis – FX (FX-001)AIRS, Inc. · 2025

https://510kreport.com/device/K120165 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120165: Intraosseous 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/K120165

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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