510(k) · Cleared

Cleared

MSP Metatarsal Shortening System

K140724510(k) TraditionalCleared May 14, 201454-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

Nextremity Solutions, Inc. · HRS Plate, Fixation, Bone

Cleared on May 14, 2014 as substantially equivalent to K063049 (Synthes (Usa), 2006) after a 54-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it.

Decided: May 14, 2014
Review: 54 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K063049 (2006). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK063049 Synthes (Usa) Modular Mini Fragment LCP SystemSynthes (Usa) · 2006 · Recalled
This deviceK140724 MSP Metatarsal Shortening SystemNextremity Solutions, Inc. · 2014
Descendant · cites it directly · 4 of its ownK182201 Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018 · Recalled
Descendant · 2 generations on · 0 of its ownK212979 CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. · 2022
Descendant · 2 generations on · 0 of its ownK213301 InCore Subtalar SystemNextremity Solutions, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
Descendant · cites it directly · 0 of its ownK200785 Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2015high 2 (2021) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all

K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018 · cites it directly4descendants
K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. · 2022 · 2 generations on0descendants
K213301InCore Subtalar SystemNextremity Solutions, Inc. · 2021 · 2 generations on0descendants
K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021 · 2 generations on0descendants
K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K063049	Synthes (Usa) Modular Mini Fragment LCP System	Synthes (Usa)	2006	4
0 (this device)	K140724	MSP Metatarsal Shortening System	Nextremity Solutions, Inc.	2014	—
+1	K182201	Stratum™ Foot Plating System	Nextremity Solutions, Inc.	2018	5
+2	K212979	CalcShift™ Displacement Calcaneal Osteotomy System	Nextremity Solutions, Inc.	2022	—
+2	K213301	InCore Subtalar System	Nextremity Solutions, Inc.	2021	—
+2	K212640	Stratum® Ankle Fusion Plating System	Nextremity Solutions, Inc.	2021	—
+1	K200785	Stratum™ Reduced Size Foot Plating System	Nextremity Solutions, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2018	1	0
2020	1	0
2021	2	0
2022	1	0

FIG. 1 — Lineage of K140724, 2006–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K063049	Synthes (Usa) Modular Mini Fragment LCP System Summary page 1 …Mini Fragment LCP System (Marketed as Modular Mini Fragment LCP System) [5.10(k) K063049] Description The Nextremnity Solutions MSPTh Metatarsal Shortening System is a set, consisting of: 1. A bone plate. 2. Sp…	Synthes (Usa)	2006	4

Also cleared against K063049: 39 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K182201	Stratum™ Foot Plating System	Nextremity Solutions, Inc.	2018	4
K200785	Stratum™ Reduced Size Foot Plating System	Nextremity Solutions, Inc.	2020	0
K152548	AXI+LINE Proximal Bunion Correction System	Nextremity Solutions, Inc.	2015	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?

Its one ancestor has a recall.
Of its descendants, K182201 (Nextremity Solutions, Inc., 2018) has gone furthest, with 4 descendants of its own.
39 other devices also cite its predicate K063049.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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	—

What is it indicated for?

The Nextremnity Solutions MSPTM System is indicated for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bane segments, particularly in osteopenic bone. Examples include, but not limited to, the hand, foot (shortening of the lesser metatarsal) and ankle.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140724: MSP Metatarsal Shortening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140724

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026