510(k) · Cleared

Cleared

Titanium TomoFix Medial High Tibia Plate Anatomical

K180213510(k) TraditionalCleared Oct 19, 2018267-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) Products, LLC · HRS Plate, Fixation, Bone

Cleared on Oct 19, 2018 as substantially equivalent to K023941 (Synthes (Usa), 2003) after a 267-day review. Its family tree reaches back 1 generation to 2003.

Decided: Oct 19, 2018
Review: 267 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023941 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK023941 Synthes Tomofix Osteotomy SystemSynthes (Usa) · 2003 · Recalled
This deviceK180213 Titanium TomoFix Medial High Tibia Plate AnatomicalSynthes (USA) Products, LLC · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023941	Synthes Tomofix Osteotomy System	Synthes (Usa)	2003	1
0 (this device)	K180213	Titanium TomoFix Medial High Tibia Plate Anatomical	Synthes (USA) Products, LLC	2018	—

FIG. 1 — Lineage of K180213, 2003–2018Source: 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

Get a 510(k) Report

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
*	K023941	Synthes Tomofix Osteotomy System Summary page 4 …component metallic bone fixation appliances and accessories. Name Predicate Titanium TomoFix™ Medial High Tibia Plate Device initially cleared via K023941 Reference TomoFix™ Medial High Tibia Plate, Small, device initially cleared via K100676 Device…	Synthes (Usa)	2003	1
†	K100676	Synthes Tomofix (TM) Meial High Tibia Plate, Small	Synthes (Usa)	2010	—

Also cleared against K023941: 8 other devices →

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?

Its one ancestor has a recall.
8 other devices also cite its predicate K023941.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures, and malalignment caused by injury or disease of the medial proximal tibia for the treatment of:

- Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia

- Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180213 · printed Nov 4, 2026

Cite this page

510(k) Report. “K180213: Titanium TomoFix Medial High Tibia Plate Anatomical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180213

Report an extraction error

Are you the manufacturer?

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