510(k) · Cleared

Recalled · Class II · 2022

Newdeal Tibiaxys System

K073375510(k) TraditionalCleared Feb 21, 200880-day reviewClass II21 CFR 888.3030Recalls 2

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

Newdeal Sas · HRS Plate, Fixation, Bone

Cleared on Feb 21, 2008 as substantially equivalent to K022255 (Synthes (Usa), 2002) and 2 other predicates after an 80-day review. Its family tree reaches back 4 generations to 2000. 73 later devices descend from it. It has been recalled 2 times.

Decided: Feb 21, 2008
Review: 80 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 3

Its longest line of descent runs back 4 generations to K000684 (2000). 19 ancestors in all, the oldest K890939 (1989). 73 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
1 generation backK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
This deviceK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008
Descendant · cites it directly · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
Descendant · cites it directly · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
Descendant · cites it directly · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
Descendant · 2 generations on · 12 of its ownK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2010high 10 (2021) · low 1 (2010)2026

Most influential descendants

Showing 5 of 73 · See all

K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · cites it directly69descendants
K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · cites it directly56descendants
K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · cites it directly53descendants
K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−3	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−2	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
−1	K033639	Acumed Lower Extremity Congruent Plate System	Acumed, LLC	2004	10
0 (this device)	K073375	Newdeal Tibiaxys System	Newdeal Sas	2008	—
+1	K110670	VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…	Smith & Nephew, Inc.	2011	—
+1	K100176	Ascension Ankle Fusion Plate System	Ascension Orthopedics, Inc.	2010	—
+1	K121425	Ortholoc 3DI Ankle Fusion Plating System	Wrightmedicaltechnologyinc	2012	—
+2	K140397	Paralock Plating System / Tuffnek Screw	Paragon 28	2014	—
+2	K163650	ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension	Wrightmedicaltechnologyinc	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1992	1	0
1995	2	0
1998	3	0
2000	1	0
2001	2	0
2002	3	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2012	2	0
2013	1	0
2014	4	0
2015	1	0
2016	1	0
2017	7	0
2018	3	0
2019	5	0
2020	7	0
2021	10	0
2022	2	0
2023	10	0
2024	6	0
2025	4	0
2026	8	0

FIG. 1 — Lineage of K073375, 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 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? (3)

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
*	K022255	Modofocation to Synthes Ankle Arthrodesis Plates Summary page 2 …lates include: 1) Anterior plates, 2) Medial or Lateral plates and 3) Fibula plates. Anterior Plates are substantially equivalent to the Synthes Ankle Arthrodesis Plate, K022255, the Newdeal TTC Plates, K060473. Medial and Lateral Plates are substantially equivalent to the Acumed Lower Extremity Congruent…	Synthes (Usa)	2002	—
*	K060473	TTC Plate Summary page 2 …, 2) Medial or Lateral plates and 3) Fibula plates. Anterior Plates are substantially equivalent to the Synthes Ankle Arthrodesis Plate, K022255, the Newdeal TTC Plates, K060473. Medial and Lateral Plates are substantially equivalent to the Acumed Lower Extremity Congruent Plate System, K033639. Fibula Pla…	New Deal, S.A.	2006	—
*	K033639	Acumed Lower Extremity Congruent Plate System Summary page 2 …Arthrodesis Plate, K022255, the Newdeal TTC Plates, K060473. Medial and Lateral Plates are substantially equivalent to the Acumed Lower Extremity Congruent Plate System, K033639. Fibula Plates are substantially equivalent to the Acumed Lower Extremity Congruent Plate System, K033639. Device Description: Th…	Acumed, LLC	2004	10

Also cleared against K022255: 3 other devices →

What descends from it? (73)

See all 73

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

Number	Device	Applicant	Decided	Descendants
K110670	VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…	Smith & Nephew, Inc.	2011	69
K100176	Ascension Ankle Fusion Plate System	Ascension Orthopedics, Inc.	2010	56
K121425	Ortholoc 3DI Ankle Fusion Plating System	Wrightmedicaltechnologyinc	2012	53
K173121	Ankle Fusion Plating System	In2bones Sas	2017	2
K202803	Activmotion S DTO	Newclip Technics	2021	0
K210016	Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…	Integra LifeSciences Corporation	2021	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 4, 2022	Class II	Z-0548-2022	Process control	The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Mar 28, 2014	Class II	Z-1697-2014	Package design/selection	New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No.…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
6 of the 19 ancestors have a recall of any class.
Of its descendants, K110670 (Smith & Nephew, Inc., 2011) has gone furthest, with 69 descendants of its own.
3 other devices also cite its predicate K022255.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.

The Newdeal TIBIAXYS Plates are fixed with the SURFIX and SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073375 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073375: Newdeal Tibiaxys System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073375

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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