510(k) · Cleared

Cleared

Intai Anatomic Locking Plate and Screw System

K201229510(k) TraditionalCleared Mar 11, 2022673-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

Intai Technology Corporation · HRS Plate, Fixation, Bone

Cleared on Mar 11, 2022 as substantially equivalent to K092609 (Synthes (Usa), 2009) and 14 other predicates after a 673-day review. Its family tree reaches back 7 generations to 1996.

Decided: Mar 11, 2022
Review: 673 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 15

Its longest line of descent runs back 7 generations to K962616 (1996). 40 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
5 generations backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
4 generations backK042598 Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · Recalled
3 generations backK050121 Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005
2 generations backK070906 Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc. · 2007 · Recalled
1 generation backK082078 Zimmer Periarticular Locking Plate System: Distal Humeral and…Zimmer, Inc. · 2008 · Recalled
This deviceK201229 Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−6	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−5	K040593	Periarticular Locking Plates and Screws, 2358, 2359 Series	Zimmer, Inc.	2004	2
−4	K042598	Periarticular Locking Plates and Screws, 2357 and 2359 Series	Zimmer, Inc.	2004	1
−3	K050121	Zimmer Periarticular Locking Plate System, Model 2357 & 2359	Zimmer, Inc.	2005	—
−2	K070906	Modificaton to: Zimmer Periarticular Locking Plates and Screws	Zimmer, Inc.	2007	21
−1	K082078	Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna…	Zimmer, Inc.	2008	7
0 (this device)	K201229	Intai Anatomic Locking Plate and Screw System	Intai Technology Corporation	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1996	2	0
1998	3	0
1999	2	0
2000	5	0
2001	3	0
2002	1	0
2003	2	0
2004	5	0
2005	1	0
2006	3	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K201229, 1996–2022Source: 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

Get a 510(k) Report

What was it cleared against? (15)

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
*	K092609	Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) Summary page 4 …Number 3.5mm/4.5mm Curved Narrow and 013 K092609 Synthes Broad Locking Compression Plates (LCP)…	Synthes (Usa)	2009	—
*	K073186	Synthes 3.5MM LCP Clavicle Plate System Summary page 4 …on Plates (LCP) Other Predicate Devices 001 K073186 Synthes 3.5mm LCP Clavicle Plate System 002 K061753 Synthes Clavicl…	Synthes (Usa)	2007	—
*	K061753	Synthes (Usa) Clavicle Hook Plates Summary page 4 …Other Predicate Devices 001 K073186 Synthes 3.5mm LCP Clavicle Plate System 002 K061753 Synthes Clavicle Hook Plate Stryker…	Synthes (Usa)	2006	—
*	K040022	Stryker Leibinger Universal Distal Radius System Summary page 4 …002 K061753 Synthes Clavicle Hook Plate Stryker 003 K040022 Universal Distal Radius System Leibinger…	Stryker Leibinger	2004	—
*	K082078	Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates Summary page 4 …Leibinger Periarticular Locking Plate System: 004 K082078 Zimmer Distal Humeral and Proximal Ulna Plate…	Zimmer, Inc.	2008	7
*	K041860	Synthes (Usa) LCP Proximal Humerus Plates, Long Summary page 4 …Plate LCP® Proximal Humerus Plates, 005 K041860 Synthes Long…	Synthes (Usa)	2004	—
*	K030597	Synthes 3.5MM Titanium LCP Proximal Tibia Plates Summary page 4 …Plate 3.5mm Titanium LCP Proximal Tibia 007 K030597 Synthes Plate 008 K013…	Synthes (Usa)	2003	—
*	K013248	Synthes LCP Distal Tibia Plates Summary page 4 …ia 007 K030597 Synthes Plate 008 K013248 Synthes LCP Distal Tibia Plate 2.7 mm/ 3.5 mm L…	Synthes (Usa)	2001	—
*	K073460	Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates Summary page 4 …Synthes LCP Distal Tibia Plate 2.7 mm/ 3.5 mm LCP Distal Fibula 009 K073460 Synthes Plates 010 K06…	Synthes (Usa)	2008	—
*	K062564	Synthes LCP Distal Femur Plates Summary page 4 …a 009 K073460 Synthes Plates 010 K062564 Synthes Synthes LCP Distal Femur Plates 3.5mm/4…	Synthes (Usa)	2006	—
*	K033805	Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates Summary page 4 …thes Synthes LCP Distal Femur Plates 3.5mm/4.5mm LCP Metaphyseal 011 K033805 Synthes Plate 012 K093…	Synthes (Usa)	2004	—
*	K093928	Synthes 3.5MM Quadrilateral Surface Plates Summary page 4 …al 011 K033805 Synthes Plate 012 K093928 Synthes 3.5 mm Quadrilateral Surface Plates 014 K042377 Synthes Low…	Synthes (Usa)	2010	—
*	K042377	Synthes Low Profile Reconstruction Plates Summary page 4 …Plate 012 K093928 Synthes 3.5 mm Quadrilateral Surface Plates 014 K042377 Synthes Low Profile Reconstruction Plates 015 K043185 Synthes 3.5mm…	Synthes (Usa)	2004	—
*	K043185	Synthes 3.5MM Cortex Screws Summary page 4 …3.5 mm Quadrilateral Surface Plates 014 K042377 Synthes Low Profile Reconstruction Plates 015 K043185 Synthes 3.5mm Cortex Screw Intai Anatomical Locking Plate and Screw System for 510(k)…	Synthes (Usa)	2005	—
*	K060710	Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws Summary page 5 …ichung City 408, Taiwan, R.O.C Universal Locking System, 3.5mm 016 K060710 Zimmer Plates And Screws-4936 Plates,4835 Screws…	Zimmer, Inc.	2006	5

Also cleared against K092609: 10 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?

The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
10 of the 40 ancestors have a recall of any class.
10 other devices also cite its predicate K092609.

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 Intai Anatomy Locking Plate and Screw System is provided non-sterile.

The system is intended for use in fixation of fractures to the various bones, including: clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults.

This system is not indicated for use in the spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201229 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201229: Intai Anatomic Locking Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201229

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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