510(k) · Cleared

Recalled · Class II · 2017

Steinmann (Threaded/Calibrated),Knowles&Hogie Pins

K863734510(k) TraditionalCleared Oct 20, 198627-day reviewClass II21 CFR 888.3040Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Micro-Aire Surgical Instruments, Inc. · HTY Pin, Fixation, Smooth

Cleared on Oct 20, 1986 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided: Oct 20, 1986
Review: 27 days
Class: Class II
Product code: HTY
Recalls: 1
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK863734 Steinmann (Threaded/Calibrated),Knowles&Hogie PinsMicro-Aire Surgical Instruments, Inc. · 1986
Descendant · cites it directly · 1 of its ownK083144 Acumed Clavicle Screw SystemAcumed, LLC · 2009
Descendant · 2 generations on · 0 of its ownK242896 Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025
Descendant · cites it directly · 0 of its ownK152627 IFS Fixation Scaffold SystemMetric Medical Devices, Inc. · 2016

Most influential descendants

Showing 3 of 3 · See all

K083144Acumed Clavicle Screw SystemAcumed, LLC · 2009 · cites it directly1descendant
K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025 · 2 generations on0descendants
K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K863734	Steinmann (Threaded/Calibrated),Knowles&Hogie Pins	Micro-Aire Surgical Instruments, Inc.	1986	—
+1	K083144	Acumed Clavicle Screw System	Acumed, LLC	2009	—
+2	K242896	Caliber Intramedullary Fixation System	Nvision Biomedical Technologies	2025	—
+1	K152627	IFS Fixation Scaffold System	Metric Medical Devices, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2016	1	0
2025	1	0

FIG. 1 — Lineage of K863734, 1986–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K083144	Acumed Clavicle Screw System	Acumed, LLC	2009	1
K152627	IFS Fixation Scaffold System	Metric Medical Devices, Inc.	2016	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 21, 2017	Class II	Z-1407-2017	Labeling mix-ups	Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K083144 (Acumed, LLC, 2009) has gone furthest, with 1 descendant 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

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	—

https://510kreport.com/device/K863734 · printed Nov 5, 2026

Cite this page

510(k) Report. “K863734: Steinmann (Threaded/Calibrated),Knowles&Hogie Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K863734

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026