510(k) · Cleared

Cleared

Normed Extremity Titanium Hand and Small Fragment System

K011118510(k) TraditionalCleared Jul 20, 200199-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

Osteomedics · HRS Plate, Fixation, Bone

Cleared on Jul 20, 2001 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 361 later devices descend from it.

Decided: Jul 20, 2001
Review: 99 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK011118 Normed Extremity Titanium Hand and Small Fragment SystemOsteomedics · 2001
Descendant · cites it directly · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
Descendant · 2 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
Descendant · 3 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
Descendant · 4 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010

Showing 5 of 361 descendants. See all descendants

Descendants cleared per year

2004high 41 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 361 · See all

K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · cites it directly360descendants
K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 2 generations on343descendants
K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 3 generations on342descendants
K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 4 generations on339descendants
K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011118	Normed Extremity Titanium Hand and Small Fragment System	Osteomedics	2001	—
+1	K040598	KLS Martin Hand Plating System	KLS-Martin L.P.	2004	—
+2	K050868	Maxlock	Orthohelix Surgical Designs, Inc.	2005	—
+3	K073624	Modular Foot System	Orthohelix Surgical Designs, Inc.	2008	1
+4	K100618	Maxlock Extreme Extremity Plating System with Variable Angle Technology	Orthohelix Surgical Designs, Inc.	2010	—
+4	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2008	1	0
2010	4	0
2011	2	0
2012	14	0
2013	8	0
2014	16	0
2015	25	0
2016	14	0
2017	31	0
2018	16	0
2019	19	0
2020	28	0
2021	24	0
2022	24	0
2023	29	0
2024	41	0
2025	25	0
2026	38	0

FIG. 1 — Lineage of K011118, 2001–2026Source: 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? (361)

See all 361

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

Number	Device	Applicant	Decided	Descendants
K040598	KLS Martin Hand Plating System	KLS-Martin L.P.	2004	360
K140397	Paralock Plating System / Tuffnek Screw	Paragon 28	2014	31

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, K040598 (KLS-Martin L.P., 2004) has gone furthest, with 360 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/K011118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011118: Normed Extremity Titanium Hand and Small Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011118

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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