510(k) Report

510(k) · Cleared

Cleared

DIP Arthrodesis System

K173616510(k) TraditionalCleared Jan 19, 201858-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

In2bones Sas · HTY Pin, Fixation, Smooth

Cleared on Jan 19, 2018 as substantially equivalent to K990804 (Pioneer Surgical Technology, 1999) and 3 other predicates after a 58-day review. Its family tree reaches back 4 generations to 1996.

Decided
Jan 19, 2018
Review
58 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K960385 (1996). 12 ancestors in all, the oldest K901456 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1999: 1 other ancestor2003: 1 other ancestor1997: 2 other ancestors1998: 1 other ancestor1990: 1 other ancestorK960385 · 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 · 2007K133477 · Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis · Synchro Medical · 20141990199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors K133477 · Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis · Synchro Medical · 2014K070598 · 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
  1. Root · 4 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. 3 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. 2 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  4. 1 generation backK133477 Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical · 2014
  5. This deviceK173616 DIP Arthrodesis SystemIn2bones Sas · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
−3K022599Newdeal K WireNew Deal, S.A.2002—
−2K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies2007—
−1K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical2014—
0 (this device)K173616DIP Arthrodesis SystemIn2bones Sas2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199720
199810
199910
200120
200310
FIG. 1 — Lineage of K173616, 1996–2018Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K990804Stayfuse
Summary page 5
…DIP Arthrodesis System is supplied sterile, using gamma irradiation. Predicate Devices Primary predicate: StayFuse (K990804), Pioneer, acquired by Tornier Additional predicates: X-Fuse (K070598), MemoMetal…
Pioneer Surgical Technology19992
*K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
Summary page 5
…Primary predicate: StayFuse (K990804), Pioneer, acquired by Tornier Additional predicates: X-Fuse (K070598), MemoMetal Implants, acquired by Stryker ToeGrip (K133477), Synchro Medical Reunit…
Memometal Technologies2007—
*K133477Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis
Summary page 5
…y Tornier Additional predicates: X-Fuse (K070598), MemoMetal Implants, acquired by Stryker ToeGrip (K133477), Synchro Medical Reunite Resorbable bone pins (K011522), Biomet Indications for use: The DIP Arthrodes…
Synchro Medical2014—
*K011522Resorbable Bone Pins
Summary page 5
…X-Fuse (K070598), MemoMetal Implants, acquired by Stryker ToeGrip (K133477), Synchro Medical Reunite Resorbable bone pins (K011522), Biomet Indications for use: The DIP Arthrodesis System is indicated for distal interphalangeal joint…
Biomet, Inc.2001—

Also cleared against K990804: 7 other devices →

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 22 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K990804.

How does its category compare?

All HTY devices

HTY 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

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 DIP implants are indicated for distal interphalangeal joint fusion of the long fingers. Treatment may include

complementary immobilization of the finger (e.g. splint) if considered preferable by the surgeon.

Indications for use as stated in the FDA summary.

Also cleared against K990804

7 other devices cite the same predicate.

  • K1626852-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017
  • K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC · 2014
  • K130019J-Screw Compression ScrewCompetitive Engineering, Inc. · 2014
  • K130859Hammertoe Correction SystemArthrosurface, Inc. · 2013
  • K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
  • K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 20116 recalls

More from In2bones Sas

18 FDA decisions under this applicant name. See the company

  • K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2024
  • K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2023
  • K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021
  • K191380Quantum® Total Ankle ProsthesisIn2bones Sas · 2020
  • K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas · 2018

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/K173616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173616: DIP Arthrodesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173616

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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