510(k) · Cleared

Cleared

Kirschner Wires, Steinmann Pins

K143618510(k) TraditionalCleared Feb 6, 201549-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

Zimmer, Inc. · HTY Pin, Fixation, Smooth

Cleared on Feb 6, 2015 as substantially equivalent to K831005 (Kirschner Medical Corp., 1983) after a 49-day review. Its family tree reaches back 1 generation to 1983. 7 later devices descend from it.

Decided: Feb 6, 2015
Review: 49 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K831005 (1983). 7 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK831005 Wire & Steinman PinsKirschner Medical Corp. · 1983 · Recalled
This deviceK143618 Kirschner Wires, Steinmann PinsZimmer, Inc. · 2015
Descendant · cites it directly · 2 of its ownK241014 Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
Descendant · 2 generations on · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
Descendant · cites it directly · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
Descendant · 2 generations on · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
Descendant · 2 generations on · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016high 3 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all

K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024 · cites it directly2descendants
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · 2 generations on1descendant
K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. · 2016 · cites it directly1descendant
K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026 · 2 generations on0descendants
K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K831005	Wire & Steinman Pins	Kirschner Medical Corp.	1983	15
0 (this device)	K143618	Kirschner Wires, Steinmann Pins	Zimmer, Inc.	2015	—
+1	K241014	Biomet Kirschner Wires (K-Wires)	Biomet, Inc.	2024	—
+2	K253718	enHAnce PEEK Bunion System	Nvision Biomedical Technologies, Inc.	2026	—
+1	K151848	Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle…	Zimmer, Inc.	2016	—
+2	K262098	EnHAnce PEEK Bunion System	Nvision Biomedical Technologies	2026	—
+2	K261271	Cable-Ready® Cable Grip System	Pioneer Surgical Technology, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	2	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K143618, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K831005	Wire & Steinman Pins Summary page 4 …ication Panel: Orthopedics/87 Predicate Device(s): Kirschner Medical Corp., Kirschner Wire and Steinman Pins (K831005 - cleared 05/18/1983) Purpose and Device Description: Zimmer Kirschner Wires and Steinmann Pins are used for…	Kirschner Medical Corp.	1983	15

Also cleared against K831005: 2 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K241014	Biomet Kirschner Wires (K-Wires)	Biomet, Inc.	2024	2
K151848	Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System	Zimmer, Inc.	2016	1
K252657	Impact PEEK Union Nail System	Nvision Biomedical Technologies, Inc.	2025	0
K160791	AmorChem Titanium Porous Fixation Device	Amorchem Holdings, Inc.	2016	0

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?

Its one ancestor has a recall.
Of its descendants, K241014 (Biomet, Inc., 2024) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K831005.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · HTY

5in 2025

2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	112	0	46
2008	6	86	0	38
2009	2	—	1	36
2010	9	180	1	33
2011	6	82	0	164
2012	4	76	0	129
2013	4	128	0	187
2014	8	73	0	149
2015	8	101	0	121
2016	6	114	2	128
2017	5	127	0	82
2018	4	162	0	138
2019	4	93	1	222
2020	5	108	0	210
2021	5	137	0	148
2022	4	121	2	96
2023	5	146	0	153
2024	1	—	0	297
2025	5	90	0	39
2026	2	—	1	—

What is it indicated for?

Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded or unthreaded form depending upon the desired application.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143618 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143618: Kirschner Wires, 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/K143618

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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