510(k) Report

510(k) · Cleared

Cleared

Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220

K983121510(k) TraditionalCleared Oct 5, 199827-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

Syntec Scientific Corp. · HTY Pin, Fixation, Smooth

Cleared on Oct 5, 1998 after a 27-day review. The FDA summary names no predicate by number. 127 later devices descend from it.

Decided
Oct 5, 1998
Review
27 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

127 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared2016: 7 descendants cleared2000: 1 descendant cleared2020: 8 descendants cleared2001: 2 descendants cleared2011: 7 descendants cleared2015: 12 descendants cleared2021: 10 descendants cleared2014: 16 descendants cleared2012: 7 descendants cleared2007: 2 descendants cleared2010: 4 descendants cleared2013: 4 descendants cleared2003: 1 descendant cleared2019: 8 descendants cleared2017: 8 descendants cleared2005: 1 descendant cleared2018: 4 descendants cleared2022: 4 descendants cleared2023: 5 descendants cleared2024: 5 descendants cleared2025: 5 descendants cleared2026: 4 descendants cleared1995200020052010201520202025
  1. This deviceK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
  2. Descendant · cites it directly · 118 of its ownK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. Descendant · 2 generations on · 80 of its ownK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
  4. Descendant · 2 generations on · 72 of its ownK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  5. Descendant · 2 generations on · 61 of its ownK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
  6. Descendant · 2 generations on · 35 of its ownK120165 Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012

Showing 5 of 127 descendants. See all descendants

Descendants cleared per year

2000: 12001: 22002: 12003: 12005: 12006: 12007: 22010: 42011: 72012: 72013: 42014: 162015: 122016: 72017: 82018: 42019: 82020: 82021: 102022: 42023: 52024: 52025: 52026: 4
2000high 16 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 127 · See all
  • K022599Newdeal K WireNew Deal, S.A. · 2002 · cites it directly118descendants
  • K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010 · 2 generations on80descendants
  • K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007 · 2 generations on72descendants
  • K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012 · 2 generations on61descendants
  • K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983121Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160…Syntec Scientific Corp.1998—
+1K022599Newdeal K WireNew Deal, S.A.2002—
+2K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc2010—
+2K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies2007—
+2K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc2012—
+2K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200210
200310
200510
200610
200720
201040
201170
201270
201340
2014160
2015120
201670
201780
201840
201980
202080
2021100
202240
202350
202450
202550
202640
FIG. 1 — Lineage of K983121, 1998–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (127)

See all 127

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

NumberDeviceApplicantDecidedDescendants
K022599Newdeal K WireNew Deal, S.A.2002118
K153204In2Bones Kirschner wireIn2bones Sas201620
K993910Tac' PinNew Deal, S.A.200014
K061607Storm Operating Kit, Model 1-10-0Intelligent Orthopaedics, Ltd.20061
K200933Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation20200
K011875Modification to the Tac' PinNew Deal, S.A.20010
K012161Flex-NailsFixano SA20010

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?

  • Of its descendants, K022599 (New Deal, S.A., 2002) has gone furthest, with 118 descendants of its own.

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?

The Kirschner Wires and Steinmann Pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Syntec Scientific Corp.

13 FDA decisions under this applicant name. See the company

  • K111189Syntec Dental ImplantSyntec Scientific Corp. · 2012
  • K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp. · 2011
  • K092889Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp. · 2010
  • K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
  • K090839Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsSyntec Scientific Corp. · 2009

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/K983121 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983121

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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