510(k) · Cleared

Cleared

Kirschner Neer-Iii Proximal Humerus

K873073510(k) TraditionalCleared Oct 1, 198756-day reviewClass II21 CFR 888.3690

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

Kirschner Medical Corp. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Oct 1, 1987 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 178 later devices descend from it.

Decided: Oct 1, 1987
Review: 56 days
Class: Class II
Product code: HSD
Recalls: None
Predicates: 0

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

This deviceK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
Descendant · cites it directly · 176 of its ownK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
Descendant · cites it directly · 147 of its ownK961571 Cocr BI-Angular Humeral ComponentBiomet, Inc. · 1996
Descendant · 2 generations on · 146 of its ownK023063 Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · Recalled
Descendant · 2 generations on · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
Descendant · 3 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011

Showing 5 of 178 descendants. See all descendants

Descendants cleared per year

1996high 17 (2022) · low 0 (1998)2026

Most influential descendants

Showing 5 of 178 · See all

K961260Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997 · cites it directly176descendants
K961571Cocr BI-Angular Humeral ComponentBiomet, Inc. · 1996 · cites it directly147descendants
K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · 2 generations on146descendants
K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · 2 generations on138descendants
K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 3 generations on110descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K873073	Kirschner Neer-Iii Proximal Humerus	Kirschner Medical Corp.	1987	—
+1	K961260	Kirschner Sholders with Titanium Plasma Spray	Biomet, Inc.	1997	—
+1	K961571	Cocr BI-Angular Humeral Component	Biomet, Inc.	1996	—
+2	K023063	Comprehensive Humeral Fracture System	Biomet Orthopedics, Inc.	2002	2
+2	K060692	Comprehensive Primary Shoulder Stems	Biomet Manufacturing Corp	2006	6
+3	K102924	Aequalis Ascend Modular Anatomic Shoulder System	Tornier, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
2000	1	0
2002	1	0
2004	2	0
2006	2	0
2010	3	0
2011	8	0
2012	4	0
2013	10	0
2014	9	0
2015	5	0
2016	5	0
2017	8	0
2018	8	0
2019	13	0
2020	10	0
2021	15	0
2022	17	0
2023	14	0
2024	11	0
2025	15	0
2026	15	0

FIG. 1 — Lineage of K873073, 1987–2026Source: 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 HSD? 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 HSD device

#1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 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?

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

What descends from it? (178)

See all 178

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

Number	Device	Applicant	Decided	Descendants
K961260	Kirschner Sholders with Titanium Plasma Spray	Biomet, Inc.	1997	176
K961571	Cocr BI-Angular Humeral Component	Biomet, Inc.	1996	147

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, K961260 (Biomet, Inc., 1997) has gone furthest, with 176 descendants of its own.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2007high 3 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSD

757in 2025

2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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	4	72	0	128
2008	3	92	2	259
2009	0	—	2	156
2010	0	—	0	225
2011	2	—	0	241
2012	2	—	0	254
2013	4	218	0	288
2014	1	—	0	434
2015	0	—	0	574
2016	3	145	0	784
2017	0	—	3	985
2018	1	—	1	649
2019	0	—	0	830
2020	2	—	1	658
2021	0	—	0	573
2022	1	—	0	508
2023	0	—	0	586
2024	1	—	0	693
2025	0	—	0	757
2026	0	—	0	—

https://510kreport.com/device/K873073 · printed Nov 6, 2026

Cite this page

510(k) Report. “K873073: Kirschner Neer-Iii Proximal Humerus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873073

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Record history

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