510(k) Report

510(k) · Cleared

Cleared

Newdeal K Wire

K022599510(k) TraditionalCleared Oct 30, 200286-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

New Deal, S.A. · HTY Pin, Fixation, Smooth

Cleared on Oct 30, 2002 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1996. 118 later devices descend from it.

Decided
Oct 30, 2002
Review
86 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K960385 (1996). 2 ancestors in all. 118 later devices descend from it, 23 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2011: 6 descendants cleared2016: 7 descendants cleared2015: 12 descendants cleared2021: 10 descendants cleared2014: 16 descendants cleared2012: 7 descendants cleared2007: 1 descendant cleared2010: 4 descendants cleared2013: 4 descendants cleared2003: 1 descendant cleared2018: 4 descendants cleared2017: 8 descendants cleared2019: 8 descendants cleared2020: 7 descendants cleared2022: 4 descendants cleared2023: 5 descendants cleared2024: 5 descendants cleared2025: 5 descendants cleared2026: 4 descendants clearedK960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 23 descendants2 generations forward: 48 descendants3 generations forward: 27 descendants4 generations forward: 14 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 19960+5
  1. Root · 1 generation backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. This deviceK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. Descendant · cites it directly · 80 of its ownK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
  4. Descendant · cites it directly · 72 of its ownK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  5. Descendant · cites it directly · 61 of its ownK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
  6. Descendant · cites it directly · 35 of its ownK120165 Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012
  7. Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12010: 42011: 62012: 72013: 42014: 162015: 122016: 72017: 82018: 42019: 82020: 72021: 102022: 42023: 52024: 52025: 52026: 4
2003high 16 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 118 · See all
  • K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010 · cites it directly80descendants
  • K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007 · cites it directly72descendants
  • K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012 · cites it directly61descendants
  • K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012 · cites it directly35descendants
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
0 (this device)K022599Newdeal K WireNew Deal, S.A.2002—
+1K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc2010—
+1K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies2007—
+1K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc2012—
+1K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.2012—
+2K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
201040
201160
201270
201340
2014160
2015120
201670
201780
201840
201980
202070
2021100
202240
202350
202450
202550
202640
FIG. 1 — Lineage of K022599, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K960385Sterile Kirschner Wires and Steinmann Pins
Summary page 2
…ion. M. PREDICATE DEVICE: The NEWDEAL K WIRE is substantially equivalent to the DePuy Kirschner wires and Steinmann pins (K960385) and Kirschner wires and Steinmann pins from Syntec- Taichung…
Depuy, Inc.1996—
*K983121Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…
Summary page 2
…mann pins (K960385) and Kirschner wires and Steinmann pins from Syntec- Taichung Medical Instruments (K983 121). N. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: NEWDEAL K WIRES, Kirschner wires, Steinmann ins…
Syntec Scientific Corp.1998—

Also cleared against K960385: 16 other devices →

What descends from it? (118)

See all 118

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

NumberDeviceApplicantDecidedDescendants
K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc201080
K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies200772
K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc201261
K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.201235
K111536Metasurg Digifuse ImplantMetasurg201130
K132895WMT Implantable K-WireWrightmedicaltechnologyinc201327
K153204In2Bones Kirschner wireIn2bones Sas201620
K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC201116
K030336Kmedic External Fixation DevicesTeleflex Medical Group200316
K100926Arrowhead Fixation DeviceArrow Products, Inc.201010

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K101165 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 80 descendants of its own.
  • 16 other devices also cite its predicate K960385.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

NEWDEAL K WIRE is indicated for :

- use in Fixation of bone fractures,

- bone reconstruction,

- as guide pins for insertion of other implants

The size of the K WIRE should be adapted to the specific indication.

Indications for use as stated in the FDA summary.

Also cleared against K960385

16 other devices cite the same predicate.

  • K203605SteriTrakArbutus Medical, Inc. · 2021
  • K173910Impress SFS SystemCable Fix Medical, LLC · 2018
  • K181425APTUS® Proximal Humerus SystemMedartis AG · 2018
  • K170326dynaMX Intramedullary ImplantArthrex, Inc. · 2017
  • K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG · 2013
  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 201217 recalls

More from New Deal, S.A.

28 FDA decisions under this applicant name. See the company

  • K070160Modification to TTC PlatesNew Deal, S.A. · 2007
  • K063820Lisfranc PlateNew Deal, S.A. · 2007
  • K070241Modification to Lapidus PlateNew Deal, S.A. · 20071 recall
  • K060474Lisfranc PlateNew Deal, S.A. · 2006
  • K061765Kalix II ImplantNew Deal, S.A. · 2006

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/K022599 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022599: Newdeal K Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022599

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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