510(k) · Cleared

Cleared

Synthes (Usa) Medial Distal Tibia Plates

K001945510(k) TraditionalCleared Sep 22, 200088-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Sep 22, 2000 after an 88-day review. The FDA summary names its predicate without a number. 112 later devices descend from it.

Decided: Sep 22, 2000
Review: 88 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

112 later devices descend from it, 17 citing it directly.

This deviceK001945 Synthes (Usa) Medial Distal Tibia PlatesSynthes (Usa) · 2000
Descendant · cites it directly · 77 of its ownK102282 The Varia Fibula Locked Plating System Line Extension Addition of…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
Descendant · 2 generations on · 54 of its ownK123000 Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012
Descendant · cites it directly · 25 of its ownK063672 Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2007 · Recalled
Descendant · 3 generations on · 23 of its ownK132594 Crosscheck Plating SystemSolana Surgical, LLC · 2013 · Recalled
Descendant · 4 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2005high 17 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 112 · See all

K102282The Varia Fibula Locked Plating System Line Extension Addition of Straight PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · cites it directly77descendants
K123000Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012 · 2 generations on54descendants
K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2007 · cites it directly25descendants
K132594Crosscheck Plating SystemSolana Surgical, LLC · 2013 · 3 generations on23descendants
K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 4 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001945	Synthes (Usa) Medial Distal Tibia Plates	Synthes (Usa)	2000	—
+1	K102282	The Varia Fibula Locked Plating System Line Extension Addition of Straight…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2010	—
+2	K123000	Integra Total Foot Systems	Integra LifeSciences Corporation	2012	—
+1	K063672	Fibula Plate Prolock with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2007	1
+3	K132594	Crosscheck Plating System	Solana Surgical, LLC	2013	21
+4	K152974	ORTHOLOC® 3Di Foot Plating Reconstruction System	Wrightmedicaltechnologyinc	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2010	1	0
2012	1	0
2013	2	0
2014	3	0
2015	2	0
2016	2	0
2017	10	0
2018	7	0
2019	9	0
2020	11	0
2021	10	0
2022	9	0
2023	9	0
2024	17	0
2025	8	0
2026	9	0

FIG. 1 — Lineage of K001945, 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	Recalls
*	—	Synthes Small T-Plate Named without a submission number	—
*	—	Synthes One-Third Tubular Plate Named without a submission number	—
*	—	Synthes 3.5 mm Cortex Screw Named without a submission number	—

What descends from it? (112)

See all 112

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

Number	Device	Applicant	Decided	Descendants
K102282	The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2010	77
K063672	Fibula Plate Prolock with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2007	25
K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017	19
K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	Gpc Medical, Ltd.	2016	15
K191793	Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…	Nebula Surgical Private Limited	2019	3
K163383	GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…	Greens Surgicals Pvt., Ltd.	2017	3
K222282	HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System	Hospital Equipment Manufacturing Company	2022	1
K202912	ARIX Ankle Distal Tibia System	Jeil Medical Corporation	2020	1
K153374	CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…	Orthocare	2016	1
K141680	AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…	Auxein Medical	2015	1

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, K102282 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2010) has gone furthest, with 77 descendants of its own.

How does its category compare?

All HRS devices

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

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?

Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, .ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K001945 · printed Nov 4, 2026

Cite this page

510(k) Report. “K001945: Synthes (Usa) Medial Distal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001945

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026