510(k) · Cleared

Cleared

Locking Compression Plate

K101400510(k) TraditionalCleared Nov 9, 2010175-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

Changzhou Orthmed Medical Instrument Co., Ltd. · HRS Plate, Fixation, Bone

Cleared on Nov 9, 2010 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided: Nov 9, 2010
Review: 175 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

13 later devices descend from it, 6 citing it directly.

This deviceK101400 Locking Compression PlateChangzhou Orthmed Medical Instrument Co., Ltd. · 2010
Descendant · cites it directly · 7 of its ownK130340 Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013
Descendant · 2 generations on · 2 of its ownK133840 Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
Descendant · 2 generations on · 1 of its ownK143002 Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
Descendant · 2 generations on · 1 of its ownK150009 BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015
Descendant · cites it directly · 1 of its ownK131759 Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012high 3 (2013) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all

K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013 · cites it directly7descendants
K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014 · 2 generations on2descendants
K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · 2 generations on1descendant
K150009BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015 · 2 generations on1descendant
K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K101400	Locking Compression Plate	Changzhou Orthmed Medical Instrument Co., Ltd.	2010	—
+1	K130340	Locking Bone Plates and Screws	Weigao Orthopaedic Device Co., Ltd.	2013	—
+2	K133840	Kangli Locking Plate System	Suzhou Kangli Orthopaedics Instrument Co., Ltd.	2014	—
+2	K143002	Metallic Locking Bone Plate and Screw System	Changzhou Dingjian Medical Appliance Co., Ltd.	2015	—
+2	K150009	Baide	Jiangsu Baide Medical Intrument Co., Ltd.	2015	—
+1	K131759	Metallic Locking Compression Bone Plates and Screws System	Tianjin Walkman Biomaterial Co., Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	3	0
2014	2	0
2015	3	0
2016	1	0
2017	1	0
2020	1	0
2025	1	0

FIG. 1 — Lineage of K101400, 2010–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K130340	Locking Bone Plates and Screws	Weigao Orthopaedic Device Co., Ltd.	2013	7
K131759	Metallic Locking Compression Bone Plates and Screws System	Tianjin Walkman Biomaterial Co., Ltd.	2013	1
K162380	Locking Plate System	Beijing Keyi Medical Device Technology Co., Ltd.	2017	0
K151508	IRENE Locking Compression Plate System	Tianjin Zhengtian Medical Instrument Co., Ltd.	2016	0
K132642	Locking Plate System	Beijing Libeier Bio-Engineering Institute Co., Ltd.	2013	0
K112798	Locking Compression Plate System	Shanghai Microport Orthopedics Co., Ltd.	2012	0

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, K130340 (Weigao Orthopaedic Device Co., Ltd., 2013) has gone furthest, with 7 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. 2010, 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	—

https://510kreport.com/device/K101400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101400: Locking Compression Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101400

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026