510(k) · Cleared

Cleared

Syntec Osteo-Plate and Screw Fixation

K092889510(k) TraditionalCleared Jun 25, 2010277-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

Syntec Scientific Corp. · HRS Plate, Fixation, Bone

Cleared on Jun 25, 2010 as substantially equivalent to K983495 (Syntec Scientific Corp., 1998) after a 277-day review. Its family tree reaches back 1 generation to 1998. 13 later devices descend from it.

Decided: Jun 25, 2010
Review: 277 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983495 (1998). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
This deviceK092889 Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp. · 2010
Descendant · cites it directly · 9 of its ownK130108 Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013
Descendant · 2 generations on · 1 of its ownK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
Descendant · 2 generations on · 1 of its ownK221088 Anatomic Bone PlateDouble Medical Technology, Inc. · 2023
Descendant · 2 generations on · 1 of its ownK220921 Metal Bone ScrewDouble Medical Technology, Inc. · 2022
Descendant · cites it directly · 1 of its ownK112819 Reconstruction Locking Plate and 3.5MM Locking ScrewXiamen Double Engline Medical Material Co., Ltd. · 2011

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011high 3 (2015) · low 0 (2012)2026

Most influential descendants

Showing 5 of 13 · See all

K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013 · cites it directly9descendants
K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023 · 2 generations on1descendant
K221088Anatomic Bone PlateDouble Medical Technology, Inc. · 2023 · 2 generations on1descendant
K220921Metal Bone ScrewDouble Medical Technology, Inc. · 2022 · 2 generations on1descendant
K112819Reconstruction Locking Plate and 3.5MM Locking ScrewXiamen Double Engline Medical Material Co., Ltd. · 2011 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983495	Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…	Syntec Scientific Corp.	1998	—
0 (this device)	K092889	Syntec Osteo-Plate and Screw Fixation	Syntec Scientific Corp.	2010	—
+1	K130108	Double Engine Bone Plate and Screw Systems	Xiamen Double Engine Medical Material Co., Ltd.	2013	—
+2	K221150	Advanced Bone Plate	Double Medical Technology, Inc.	2023	—
+2	K221088	Anatomic Bone Plate	Double Medical Technology, Inc.	2023	—
+2	K220921	Metal Bone Screw	Double Medical Technology, Inc.	2022	—
+1	K112819	Reconstruction Locking Plate and 3.5MM Locking Screw	Xiamen Double Engline Medical Material Co., Ltd.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2015	3	0
2016	1	0
2022	1	0
2023	3	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K092889, 1998–2025Source: 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? (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
*	K983495	Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120… Summary page 1 …888.3030, 888.3040 Class :I Predicate device: Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495) Preparation of the date: August 01, 2009 Material: The Syntec Osteo-plate and screw Fixation provides two materials…	Syntec Scientific Corp.	1998	—

Also cleared against K983495: 10 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K130108	Double Engine Bone Plate and Screw Systems	Xiamen Double Engine Medical Material Co., Ltd.	2013	9
K112819	Reconstruction Locking Plate and 3.5MM Locking Screw	Xiamen Double Engline Medical Material Co., Ltd.	2011	1
K150188	SMV Scientific 4.5 mm Bone Screws	Summit Medventures	2015	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?

Its one ancestor has no recall.
Of its descendants, K130108 (Xiamen Double Engine Medical Material Co., Ltd., 2013) has gone furthest, with 9 descendants of its own.
10 other devices also cite its predicate K983495.

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	—

What is it indicated for?

Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092889 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092889: Syntec Osteo-Plate and Screw Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092889

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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