510(k) · Cleared

Cleared

I.C.S. Mini & Small Fragment Set

K800806510(k) TraditionalCleared Apr 21, 198011-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

Howmedica Corp. · HRS Plate, Fixation, Bone

Cleared on Apr 21, 1980 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 118 later devices descend from it.

Decided: Apr 21, 1980
Review: 11 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK800806 I.C.S. Mini & Small Fragment SetHowmedica Corp. · 1980
Descendant · cites it directly · 117 of its ownK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
Descendant · 2 generations on · 113 of its ownK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
Descendant · 2 generations on · 92 of its ownK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
Descendant · 3 generations on · 68 of its ownK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
Descendant · 3 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

1999high 17 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 118 · See all

K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999 · cites it directly117descendants
K021321Wrist Fusion PlateAcu Med, Inc. · 2002 · 2 generations on113descendants
K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005 · 2 generations on92descendants
K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009 · 3 generations on68descendants
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 3 generations on58descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K800806	I.C.S. Mini & Small Fragment Set	Howmedica Corp.	1980	—
+1	K991873	Kmi Wrist Fusion System	Kinetikos Medical, Inc.	1999	—
+2	K021321	Wrist Fusion Plate	Acu Med, Inc.	2002	—
+2	K050681	Omnitech System & Easy Lock Osteosystem with Xtremities Plates	TriMed, Inc.	2005	—
+3	K092670	Biodrive Micro Screw System	Ebi,Llc D/B/A Biomet Trauma	2009	—
+3	K111678	Ortho Solutions Extremity Fixation Implants for Osteosysnthesis	Ortho Solutions Limited	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2003	1	0
2005	1	0
2009	2	0
2010	1	0
2011	2	0
2012	2	0
2013	7	0
2014	4	0
2015	8	0
2016	5	0
2017	12	0
2018	1	0
2019	4	0
2020	6	0
2021	5	0
2022	6	0
2023	17	0
2024	12	0
2025	8	0
2026	12	0

FIG. 1 — Lineage of K800806, 1980–2026Source: 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 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? (118)

See all 118

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

Number	Device	Applicant	Decided	Descendants
K991873	Kmi Wrist Fusion System	Kinetikos Medical, Inc.	1999	117

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, K991873 (Kinetikos Medical, Inc., 1999) has gone furthest, with 117 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/K800806 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800806: I.C.S. Mini & Small Fragment Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800806

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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