510(k) · Cleared

Cleared

Endotine Midface B 4.5 Device

K041835510(k) TraditionalCleared Sep 28, 200483-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coapt Systems, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 28, 2004 as substantially equivalent to K032698 (Coapt Systems, Inc., 2003) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 2002.

Decided: Sep 28, 2004
Review: 83 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K014153 (2002). 4 ancestors in all, the oldest K974309 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
2 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
1 generation backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
This deviceK041835 Endotine Midface B 4.5 DeviceCoapt Systems, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K014153	Coapt Systmes Endotine Device	Coapt Systems, Inc.	2002	—
−2	K023922	Coapt Systems Endotine Device, Model CFD-101-00197	Coapt Systems, Inc.	2002	—
−1	K032698	Coapt Endotine Midface-ST 4.5 Device	Coapt Systems, Inc.	2003	—
0 (this device)	K041835	Endotine Midface B 4.5 Device	Coapt Systems, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K041835, 2002–2004Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (2)

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
*	K032698	Coapt Endotine Midface-ST 4.5 Device Summary page 2 …510(k) or PMA Number ENDOTINE MidfaceTM-ST Coapt Systems, Inc K032698 4.5 Device LactoSorb® Panels Walter Lorenz Surgical K974309 DEVICE DESCRIPTION The ENDOTINE Midfac…	Coapt Systems, Inc.	2003	—
*	K974309	Lactosorb Panels Summary page 2 …Number ENDOTINE MidfaceTM-ST Coapt Systems, Inc K032698 4.5 Device LactoSorb® Panels Walter Lorenz Surgical K974309 DEVICE DESCRIPTION The ENDOTINE MidfaceTM-ST 4.5 consists of two components: (1) a fixation platform with anchoring leash, and…	Biomet, Inc.	1998	—

Also cleared against K032698: 1 other device →

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 2 years and passes through 1 company; a new generation was cleared every 10 months on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K032698.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The ENDOTINE Midface B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041835 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041835: Endotine Midface B 4.5 Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041835

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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