510(k) · Cleared

Cleared

Modification to Classic Great Toe Implant

K023562510(k) SpecialCleared Nov 13, 200221-day reviewClass II21 CFR 888.3720

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

Nexa Orthopedics, Inc. · KWH Prosthesis, Toe, Constrained, Polymer

Cleared on Nov 13, 2002 as substantially equivalent to K023086 (Nexa Orthopedics, Inc., 2002) after a 21-day review. Its family tree reaches back 3 generations to 1978.

Decided: Nov 13, 2002
Review: 21 days
Class: Class II
Product code: KWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K780132 (1978). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK780132 Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 1978
2 generations backK981194 Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998
1 generation backK023086 Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002
This deviceK023562 Modification to Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K780132	Implant, Hinge Toe, Flex.	Dow Corning Corp. Healthcare Industries Materials	1978	—
−2	K981194	Futura Biomedical Flexible Great Toe Implant	Nexa Orthopedics, Inc.	1998	—
−1	K023086	Classic Great Toe Implant	Nexa Orthopedics, Inc.	2002	—
0 (this device)	K023562	Modification to Classic Great Toe Implant	Nexa Orthopedics, Inc.	2002	—

FIG. 1 — Lineage of K023562, 1978–2002Source: 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 KWH? 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 KWH device

#1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall

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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
*	K023086	Classic Great Toe Implant Summary page 1 …87 KWH Original Predicate Device: Futura Biomedical Classic Great Toe Implant - k023086 Registration Number: 2030833 Owner Operator Number: 90283 19 Device Descrip…	Nexa Orthopedics, Inc.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All KWH devices

KWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWH

1in 2020

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWH

Too few KWH 510(k)s in any year since 2007 to give a median.

Recalls per year · KWH

2in 2009

2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KWH

8in 2025

2007high 15 (2019) · low 2 (2007)2025

MAUDE reports naming product code KWH, 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	0	—	0	2
2008	0	—	0	4
2009	0	—	2	5
2010	0	—	0	3
2011	1	—	0	2
2012	0	—	0	6
2013	0	—	0	5
2014	0	—	0	6
2015	0	—	0	6
2016	1	—	0	6
2017	0	—	0	3
2018	1	—	0	7
2019	1	—	0	15
2020	1	—	0	8
2021	0	—	0	5
2022	0	—	0	5
2023	0	—	0	6
2024	0	—	0	2
2025	0	—	0	8
2026	0	—	0	—

What is it indicated for?

Futura Biomedical Classic Great Toe Implant is indicated for:

Hallux limitus or hallux rigidus

Painful rheumatoid arthritis

Hallux abducto valgus associated with arthritis

Unstable or painful joint from previous surgery

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023562: Modification to Classic Great Toe Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023562

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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