510(k) · Cleared

Cleared

FlexitSystem Knee osteotomy system

K212545510(k) TraditionalCleared Feb 11, 2022183-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

Neosteo · HRS Plate, Fixation, Bone

Cleared on Feb 11, 2022 as substantially equivalent to K100676 (Synthes (Usa), 2010) and 3 other predicates after a 183-day review. Its family tree reaches back 2 generations to 2002.

Decided: Feb 11, 2022
Review: 183 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K014155 (2002). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK014155 Opening/Closing Wedge Ostetomy PlatesArthrex, Inc. · 2002
1 generation backK041601 Surfix Knee Osteotomy SystemSurfix Technologies · 2004
This deviceK212545 FlexitSystem Knee osteotomy systemNeosteo · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K014155	Opening/Closing Wedge Ostetomy Plates	Arthrex, Inc.	2002	—
−1	K041601	Surfix Knee Osteotomy System	Surfix Technologies	2004	—
0 (this device)	K212545	FlexitSystem Knee osteotomy system	Neosteo	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2008	1	0
2010	1	0

FIG. 1 — Lineage of K212545, 2002–2022Source: 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? (4)

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
*	K100676	Synthes Tomofix (TM) Meial High Tibia Plate, Small Summary page 5 …K212545 510(k) Summary Primary Predicate Device Tomofix® small stature (K100676) from Synthes USA Surfix® Knee osteotomy system (K041601) from Surfix Technologies SA Addi…	Synthes (Usa)	2010	—
*	K041601	Surfix Knee Osteotomy System Summary page 5 …) Summary Primary Predicate Device Tomofix® small stature (K100676) from Synthes USA Surfix® Knee osteotomy system (K041601) from Surfix Technologies SA Additional Predicate Devices TomoFix Osteotomy System(K023941…	Surfix Technologies	2004	—
*	K023941	Synthes Tomofix Osteotomy System Summary page 5 …Surfix® Knee osteotomy system (K041601) from Surfix Technologies SA Additional Predicate Devices TomoFix Osteotomy System(K023941) from Synthes USA. TomoFix Medial Distal Femur Plates (K081353) from Synthes USA. R…	Synthes (Usa)	2003	1
*	K081353	Synthes (Usa) Tomofix Medial Distal Femur Plates Summary page 5 …ces TomoFix Osteotomy System(K023941) from Synthes USA. TomoFix Medial Distal Femur Plates (K081353) from Synthes USA. Reference device ActivMotion Range (K173746) from Newclip Technics III. D…	Synthes (Usa)	2008	—
†	K173746	Activmotion Range	Newclip Technics	2018	—

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?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 17.5 years on median.
1 of the 5 ancestors has a recall of any class.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.

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/K212545 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212545: FlexitSystem Knee osteotomy system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212545

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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