510(k) · Cleared

Cleared

Imtec Biopin

K982951510(k) TraditionalCleared Jun 21, 1999301-day reviewClass II21 CFR 872.4880

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

Imtec Corp. · DZL Screw, Fixation, Intraosseous

Cleared on Jun 21, 1999 as substantially equivalent to K974392 (Biovision GmbH, 1998) and 2 other predicates after a 301-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jun 21, 1999
Review: 301 days
Class: Class II
Product code: DZL
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K955369 (1996). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK955369 MemfixThe Straumann Co. · 1996
1 generation backK974392 Leadfix Bioresorbable Membrance Pin SystemBiovision GmbH · 1998
This deviceK982951 Imtec BiopinImtec Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955369	Memfix	The Straumann Co.	1996	—
−1	K974392	Leadfix Bioresorbable Membrance Pin System	Biovision GmbH	1998	—
0 (this device)	K982951	Imtec Biopin	Imtec Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	4	0
1997	1	0
1998	1	0

FIG. 1 — Lineage of K982951, 1996–1999Source: 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 DZL? 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 DZL device

#1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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	Applicant	Decided	Recalls
*	K974392	Leadfix Bioresorbable Membrance Pin System Summary page 1 …21 CFR 8722.4880); Product Code: DZL Common/ Usual Name: Membrane fixation pin. Proprietary Name: IMTEC BioPin. PREDICATE DEVICE: LEADfix Bioresorbable Membrane Pin ( K974392) 31 Bioresorbable Fixation Tack (K972480) Synthes Fixation System (K974554) DEVICE DESCRIPTION: The IMTEC BioPin is a bioresorb…	Biovision GmbH	1998	—
*	K972480	3I Bioresorbable Fixation Tack Summary page 1 …mon/ Usual Name: Membrane fixation pin. Proprietary Name: IMTEC BioPin. PREDICATE DEVICE: LEADfix Bioresorbable Membrane Pin ( K974392) 31 Bioresorbable Fixation Tack (K972480) Synthes Fixation System (K974554) DEVICE DESCRIPTION: The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize…	Implant Innovations, Inc.	1997	—
*	K974554	Synthes Resorbable Fixation System Summary page 1 …pin. Proprietary Name: IMTEC BioPin. PREDICATE DEVICE: LEADfix Bioresorbable Membrane Pin ( K974392) 31 Bioresorbable Fixation Tack (K972480) Synthes Fixation System (K974554) DEVICE DESCRIPTION: The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize bioresorbable barrier membranes i…	Synthes (Usa)	1998	—

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 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
1 of the 8 ancestors has a recall of any class.

How does its category compare?

All DZL devices

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

FDA decisions per year · DZL

4in 2025

2007high 4 (2025) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZL

263in 2025

2007high 277 (2017) · low 89 (2010)2026

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

Recalls per year · DZL

3in 2013

2007high 3 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DZL

70in 2025

2007high 236 (2012) · low 1 (2008)2025

MAUDE reports naming product code DZL, 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	1	—	0	4
2008	2	—	0	1
2009	2	—	1	8
2010	3	89	1	17
2011	2	—	0	12
2012	0	—	0	236
2013	1	—	3	178
2014	2	—	0	106
2015	1	—	0	103
2016	1	—	0	34
2017	3	277	0	74
2018	0	—	0	57
2019	2	—	0	50
2020	1	—	0	85
2021	1	—	0	55
2022	0	—	0	162
2023	2	—	0	100
2024	2	—	0	106
2025	4	263	0	70
2026	1	—	0	—

What is it indicated for?

The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration

membranes during the healing process by providing an attachment mechanism.Its use is intended

to avoid a second stage surgery required to remove nonresorbable tacks and pins.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982951 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982951: Imtec Biopin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982951

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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