510(k) · Cleared

Cleared

Integra Bone Fixation System

K040860510(k) TraditionalCleared Jun 17, 200476-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

Integra LifeSciences Corporation · HRS Plate, Fixation, Bone

Cleared on Jun 17, 2004 after a 76-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided: Jun 17, 2004
Review: 76 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

11 later devices descend from it, 3 citing it directly.

This deviceK040860 Integra Bone Fixation SystemIntegra LifeSciences Corporation · 2004
Descendant · cites it directly · 6 of its ownK050492 Integra Bone Fixation SystemIntegra Lifesciences Corp. · 2005
Descendant · cites it directly · 5 of its ownK073342 Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008
Descendant · cites it directly · 3 of its ownK160177 Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · Recalled
Descendant · 2 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
Descendant · 2 generations on · 2 of its ownK191009 Arsenal Plating SystemTrilliant Surgical · 2019

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all

K050492Integra Bone Fixation SystemIntegra Lifesciences Corp. · 2005 · cites it directly6descendants
K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008 · cites it directly5descendants
K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · cites it directly3descendants
K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 2 generations on3descendants
K191009Arsenal Plating SystemTrilliant Surgical · 2019 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K040860	Integra Bone Fixation System	Integra LifeSciences Corporation	2004	—
+1	K050492	Integra Bone Fixation System	Integra Lifesciences Corp.	2005	—
+1	K073342	Salvin Dental Specialties, Inc., Fixation Screw	Salvin Dental Specialties, Inc.	2008	—
+1	K160177	Gridlock Ankle Plating System	Trilliant Surgical, Ltd.	2016	1
+2	K141764	Tristar Bone Graft Fixation System	Impladent, Ltd.	2014	—
+2	K191009	Arsenal Plating System	Trilliant Surgical	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2011	1	0
2014	1	0
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K040860, 2004–2023Source: 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? (3)

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	Recalls
*	—	TiMesh® System Named without a submission number	—
*	—	Centre-Drive Drill-Free™ Screws Named without a submission number	—
*	—	LEIBINGER® Bone Plates and Bone Screws Named without a submission number	—

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K050492	Integra Bone Fixation System	Integra Lifesciences Corp.	2005	6
K073342	Salvin Dental Specialties, Inc., Fixation Screw	Salvin Dental Specialties, Inc.	2008	5
K160177	Gridlock Ankle Plating System	Trilliant Surgical, Ltd.	2016	3

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, K050492 (Integra Lifesciences Corp., 2005) has gone furthest, with 6 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.

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 Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040860 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040860: Integra Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040860

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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