510(k) Report

510(k) · Cleared

Cleared

Kirschner Wire (K-Wire) and Steinmann Pin

K961522510(k) TraditionalCleared Sep 23, 1996154-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

Synvasive Technology, Inc. · HTY Pin, Fixation, Smooth

Cleared on Sep 23, 1996 after a 154-day review. The FDA summary names its predicate without a number. 439 later devices descend from it.

Decided
Sep 23, 1996
Review
154 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

439 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 12 descendants cleared2003: 2 descendants cleared1999: 1 descendant cleared2010: 4 descendants cleared2013: 13 descendants cleared2009: 5 descendants cleared2015: 18 descendants cleared2017: 26 descendants cleared2004: 1 descendant cleared2006: 2 descendants cleared2005: 3 descendants cleared2012: 9 descendants cleared2008: 5 descendants cleared2014: 22 descendants cleared2022: 32 descendants cleared2023: 36 descendants cleared2019: 31 descendants cleared2018: 21 descendants cleared2016: 13 descendants cleared2020: 29 descendants cleared2024: 42 descendants cleared2025: 37 descendants cleared2021: 30 descendants cleared2026: 43 descendants cleared2007: 2 descendants cleared1995200020052010201520202025
  1. This deviceK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
  2. Descendant · cites it directly · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
  3. Descendant · 2 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  4. Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  5. Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  6. Descendant · 2 generations on · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled

Showing 5 of 439 descendants. See all descendants

Descendants cleared per year

1999: 12003: 22004: 12005: 32006: 22007: 22008: 52009: 52010: 42011: 122012: 92013: 132014: 222015: 182016: 132017: 262018: 212019: 312020: 292021: 302022: 322023: 362024: 422025: 372026: 43
1999high 43 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 439 · See all
  • K990156Multitak SS ButtonsBonutti Research · 1999 · cites it directly336descendants
  • K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 2 generations on309descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · 2 generations on161descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961522Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc.1996—
+1K990156Multitak SS ButtonsBonutti Research1999—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200320
200410
200530
200620
200720
200850
200950
201040
2011120
201290
2013130
2014220
2015180
2016130
2017260
2018210
2019310
2020290
2021300
2022320
2023360
2024420
2025370
2026430
FIG. 1 — Lineage of K961522, 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? (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
*—DePuy K-Wires and Steinmann Pins
Named without a submission number
—
*—Howmedica K-Wires and Steinmann Pins
Named without a submission number
—
*—MicroAire K-Wires and Steinmann Pins
Named without a submission number
—
*—Zimmer K-Wires and Steinmann Pins
Named without a submission number
—

What descends from it? (439)

See all 439

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

NumberDeviceApplicantDecidedDescendants
K990156Multitak SS ButtonsBonutti Research1999336
K030665Bone WireStork Instrumente GmbH2003113
K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118

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, K990156 (Bonutti Research, 1999) has gone furthest, with 336 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 fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

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

More from Synvasive Technology, Inc.

10 FDA decisions under this applicant name. See the company

  • K093046Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different SizesSynvasive Technology, Inc. · 2011
  • K070108Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
  • K972508Surgical Burs and Surgical Drill BitsSynvasive Technology, Inc. · 1997
  • K950009Powergrip (TM) Compression Fixation DeviceSynvasive Technology, Inc. · 1995
  • K934336SpinalplaneSynvasive Technology, Inc. · 1995

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/K961522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961522: Kirschner Wire (K-Wire) and Steinmann Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961522

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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