510(k) · Cleared

Cleared

Kirschner (R) Small Fragment Fixation System

K864924510(k) TraditionalCleared Mar 20, 198794-day reviewClass II21 CFR 888.3030

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

Kirschner Medical Corp. · HRS Plate, Fixation, Bone

Cleared on Mar 20, 1987 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided: Mar 20, 1987
Review: 94 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK864924 Kirschner (R) Small Fragment Fixation SystemKirschner Medical Corp. · 1987
Descendant · cites it directly · 8 of its ownK972219 Orthopedic Plate SystemFerguson Medical · 1997
Descendant · 2 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
Descendant · 3 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
Descendant · 3 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
Descendant · 4 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1997high 3 (2005) · low 0 (1998)2026

Most influential descendants

Showing 5 of 10 · See all

K972219Orthopedic Plate SystemFerguson Medical · 1997 · cites it directly8descendants
K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 2 generations on7descendants
K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 3 generations on1descendant
K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 3 generations on1descendant
K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K864924	Kirschner (R) Small Fragment Fixation System	Kirschner Medical Corp.	1987	—
+1	K972219	Orthopedic Plate System	Ferguson Medical	1997	—
+2	K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	—
+3	K063709	TS-Bone Hip Tool	Orthopedic Sciences, Inc.	2007	—
+3	K040850	Tsy Shoulder Plate Implant	Orthopedic Sciences, Inc.	2004	—
+4	K072175	Titanium Hip Tool Locking Plate	Orthopedic Sciences, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	2	0
2004	1	0
2005	3	0
2006	1	0
2007	2	0

FIG. 1 — Lineage of K864924, 1987–2007Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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? (10)

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

Number	Device	Applicant	Decided	Descendants
K972219	Orthopedic Plate System	Ferguson Medical	1997	8
K022515	Biomet Calcaneal Plate	Biomet Orthopedics, Inc.	2002	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?

Of its descendants, K972219 (Ferguson Medical, 1997) has gone furthest, with 8 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

https://510kreport.com/device/K864924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864924: Kirschner (R) Small Fragment Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864924

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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