510(k) · Cleared

Cleared

The Kalix Implant

K001231510(k) TraditionalCleared Jul 11, 200085-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

New Deal, S.A. · HWC Screw, Fixation, Bone

Cleared on Jul 11, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 54 later devices descend from it.

Decided: Jul 11, 2000
Review: 85 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

54 later devices descend from it, 5 citing it directly.

This deviceK001231 The Kalix ImplantNew Deal, S.A. · 2000
Descendant · cites it directly · 49 of its ownK032902 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

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2003high 5 (2011) · low 1 (2003)2026

Most influential descendants

Showing 5 of 54 · See all

K032902Subtalar Arthrorisis ImplantNexa Orthopedics, Inc. · 2003 · cites it directly49descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001231	The Kalix Implant	New Deal, S.A.	2000	—
+1	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2006	2	0
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 K001231, 2000–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (54)

See all 54

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

Number	Device	Applicant	Decided	Descendants
K032902	Subtalar Arthrorisis Implant	Nexa Orthopedics, Inc.	2003	49
K071498	Subtalar Implant	Biomet Sports Medicine, Inc.	2007	32
K053093	Kalix II Implant, Model 141 0XX with XX	New Deal, S.A.	2005	3
K053543	Arthrex Arthoeresis Implant	Arthrex, Inc.	2006	0
K041936	Biopro Subtalar Implant	Biopro, Inc.	2004	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?

Of its descendants, K032902 (Nexa Orthopedics, Inc., 2003) has gone furthest, with 49 descendants of its own.

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	—

https://510kreport.com/device/K001231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001231: The Kalix Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001231

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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