510(k) Report

510(k) · Cleared

Cleared

Fixation (Steinmann) Pins

K013888510(k) TraditionalCleared May 1, 2002159-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

Miltex, Inc. · HTY Pin, Fixation, Smooth

Cleared on May 1, 2002 after a 159-day review. The FDA summary names no predicate by number. 315 later devices descend from it.

Decided
May 1, 2002
Review
159 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

315 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2013: 11 descendants cleared2006: 1 descendant cleared2014: 20 descendants cleared2015: 24 descendants cleared2011: 9 descendants cleared2009: 1 descendant cleared2012: 7 descendants cleared2010: 1 descendant cleared2017: 31 descendants cleared2024: 24 descendants cleared2020: 21 descendants cleared2019: 15 descendants cleared2025: 26 descendants cleared2018: 14 descendants cleared2016: 7 descendants cleared2021: 22 descendants cleared2026: 37 descendants cleared2022: 22 descendants cleared2023: 21 descendants cleared200020052010201520202025
  1. This deviceK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. Descendant · cites it directly · 314 of its ownK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. Descendant · 2 generations on · 310 of its ownK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. Descendant · 3 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
  5. Descendant · 4 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
  6. Descendant · 4 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011

Showing 5 of 315 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12009: 12010: 12011: 92012: 72013: 112014: 202015: 242016: 72017: 312018: 142019: 152020: 212021: 222022: 222023: 212024: 242025: 262026: 37
2003high 37 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 315 · See all
  • K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003 · cites it directly314descendants
  • K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006 · 2 generations on310descendants
  • K103705Low Profile ScrewsArthrex, Inc. · 2011 · 3 generations on219descendants
  • K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 4 generations on135descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 4 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
+1K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
+2K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
+3K103705Low Profile ScrewsArthrex, Inc.2011—
+4K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011—
+4K112437Arthrex Fracture SystemArthrex, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200910
201010
201190
201270
2013110
2014200
2015240
201670
2017310
2018140
2019150
2020210
2021220
2022220
2023210
2024240
2025260
2026370
FIG. 1 — Lineage of K013888, 2002–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (315)

See all 315

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003314

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, K031050 (Millennium Medical Technologies, Inc., 2003) has gone furthest, with 314 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?

1. Itis the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins bath Smooth and Threaded.

2. The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal! fixation of bone fractures.

3. The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur.

4. The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applicd to the skeletal system.

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

More from Miltex, Inc.

23 FDA decisions under this applicant name. See the company

  • K101653Miltex Thompson Cassettes; Miltex Surgical CassettesMiltex, Inc. · 2010
  • K092855Miltex Membrane Tack KitMiltex, Inc. · 2009
  • K083796Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating Syringe, Miltex…Miltex, Inc. · 2009
  • K072563Miltex Rigid Container SystemsMiltex, Inc. · 2008
  • K061033Miltex Rigid Sterilization Container System, (47 Components)Miltex, Inc. · 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/K013888 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013888: Fixation (Steinmann) Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013888

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026