510(k) · Cleared

Cleared

Lactosorb Trauma Plating System

K960988510(k) TraditionalCleared Apr 10, 199634-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

Poly-Medics,Inc. · HRS Plate, Fixation, Bone

Cleared on Apr 10, 1996 after a 34-day review. The FDA summary names no predicate by number. 95 later devices descend from it.

Decided: Apr 10, 1996
Review: 34 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

95 later devices descend from it, 5 citing it directly.

This deviceK960988 Lactosorb Trauma Plating SystemPoly-Medics,Inc. · 1996
Descendant · cites it directly · 89 of its ownK974554 Synthes Resorbable Fixation SystemSynthes (Usa) · 1998
Descendant · cites it directly · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
Descendant · cites it directly · 84 of its ownK972913 Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
Descendant · 2 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
Descendant · cites it directly · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

1998high 15 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 95 · See all

K974554Synthes Resorbable Fixation SystemSynthes (Usa) · 1998 · cites it directly89descendants
K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · cites it directly86descendants
K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998 · cites it directly84descendants
K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 2 generations on79descendants
K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960988	Lactosorb Trauma Plating System	Poly-Medics,Inc.	1996	—
+1	K974554	Synthes Resorbable Fixation System	Synthes (Usa)	1998	—
+1	K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	1998	—
+1	K972913	Macropore Protective Sheet (Protego System)	Pacific Materials and Interfaces	1998	—
+2	K993061	Stryker Leibinger Resorbable Fixation System	Stryker Instruments	1999	—
+1	K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0
1999	3	0
2000	1	0
2001	2	0
2002	3	0
2004	1	0
2005	1	0
2006	2	0
2007	2	0
2008	3	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2014	4	0
2015	3	0
2016	2	0
2018	1	0
2021	3	0
2022	4	0
2023	10	0
2024	13	0
2025	15	0
2026	12	0

FIG. 1 — Lineage of K960988, 1996–2026Source: 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (95)

See all 95

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

Number	Device	Applicant	Decided	Descendants
K974554	Synthes Resorbable Fixation System	Synthes (Usa)	1998	89
K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	1998	86
K972913	Macropore Protective Sheet (Protego System)	Pacific Materials and Interfaces	1998	84
K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	73
K073115	Orthomesh	Synthes (Usa)	2008	1

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, K974554 (Synthes (Usa), 1998) has gone furthest, with 89 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 LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.

1. Comminuted fractures of the naso-ethmoidal and infraorbital areas.

2. Comminuted fractures of the frontal sinus wall.

3. Trauma of the midface or craniofacial skeleton.

4. Reconstructive procedures of the midface or craniofacial skeleton.

This system is not designed for use in the mandible and/or full load bearing procedures.

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/K960988 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960988: Lactosorb Trauma Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960988

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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