510(k) · Cleared

Cleared

Subtalar Arthrorisis Implant

K032902510(k) TraditionalCleared Dec 15, 200389-day reviewClass II21 CFR 888.3040

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

Nexa Orthopedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 15, 2003 as substantially equivalent to K001231 (New Deal, S.A., 2000) after an 89-day review. Its family tree reaches back 1 generation to 2000. 49 later devices descend from it.

Decided: Dec 15, 2003
Review: 89 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001231 (2000). 49 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK001231 The Kalix ImplantNew Deal, S.A. · 2000
This deviceK032902 Subtalar Arthrorisis ImplantNexa Orthopedics, Inc. · 2003
Descendant · cites it directly · 32 of its ownK071498 Subtalar ImplantBiomet Sports Medicine, Inc. · 2007 · Recalled
Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
Descendant · 3 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
Descendant · 4 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
Descendant · 5 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2007high 5 (2011) · low 1 (2007)2026

Most influential descendants

Showing 5 of 49 · See all

K071498Subtalar ImplantBiomet Sports Medicine, Inc. · 2007 · cites it directly32descendants
K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on16descendants
K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 4 generations on15descendants
K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 5 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001231	The Kalix Implant	New Deal, S.A.	2000	—
0 (this device)	K032902	Subtalar Arthrorisis Implant	Nexa Orthopedics, Inc.	2003	—
+1	K071498	Subtalar Implant	Biomet Sports Medicine, Inc.	2007	7
+2	K133636	Extremity Medical Hammertoe Device	Extremity Medical, LLC	2014	—
+3	K141857	CrossTie Intraosseous Fixation System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	2015	—
+4	K151270	CrossTIE Intraosseous Fixation System	Crossroads Extremity Systems, LLC	2015	—
+5	K181872	MIS Bunion System	Crossroads Extremity Systems, LLC	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2010	2	0
2011	5	0
2012	1	0
2013	1	0
2014	3	0
2015	4	0
2016	3	0
2017	3	0
2018	1	0
2019	4	0
2020	2	0
2021	3	0
2022	1	0
2023	2	0
2024	4	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K032902, 2000–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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
*	K001231	The Kalix Implant	New Deal, S.A.	2000	—

Also cleared against K001231: 4 other devices →

What descends from it? (49)

See all 49

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

Number	Device	Applicant	Decided	Descendants
K071498	Subtalar Implant	Biomet Sports Medicine, Inc.	2007	32
K080280	Sub-Talar Lok, Model 7-11 MM	Instratek, Inc.	2008	12
K093820	Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115	Memometal Technologies	2010	8
K093055	CSTS Screw	Orthopro, LLC	2010	1
K113399	Ifs Subtalar Implant	Internal Fixation Systems, Inc.	2011	0
K081755	Fusion Medical Sti	John Riccio	2009	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 no recall.
Of its descendants, K071498 (Biomet Sports Medicine, Inc., 2007) has gone furthest, with 32 descendants of its own.
4 other devices also cite its predicate K001231.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Futura Biomedical Arthrorisis Implant is intended to treat hyperpronated foot and

stabilize the subtalar joint. It is intended to block forward, downward and medial

displacement of the talus, thus allowing normal subtalar joint motion but blocking

excessive pronation and the resulting sequela. Examples include:

Flat foot treatment in children and adolescents

Congenital flat foot

Unsuccessful long term orthopaedic treatment (shoes, insoles...)

Tarsal coalitions

Painful flat foot

Supple deformity in posterior tibial tendon dysfunction

Paralytic flat foot

Subtalar instability

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032902 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032902: Subtalar Arthrorisis Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032902

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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