510(k) · Cleared

Cleared

Macropore Protective Sheet (Protego System)

K972913510(k) TraditionalCleared Jul 30, 1998357-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

Pacific Materials and Interfaces · HRS Plate, Fixation, Bone

Cleared on Jul 30, 1998 as substantially equivalent to K960988 (Poly-Medics,Inc., 1996) and 3 other predicates after a 357-day review. Its family tree reaches back 1 generation to 1990. 84 later devices descend from it.

Decided: Jul 30, 1998
Review: 357 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K900138 (1990). 4 ancestors in all. 84 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
This deviceK972913 Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
Descendant · cites it directly · 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
Descendant · 2 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Descendant · 4 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

1999high 15 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 84 · See all

K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · cites it directly79descendants
K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants
K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 2 generations on65descendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 4 generations on45descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900138	Motech Titanium Surgical Mesh	Biedermann Motech GmbH	1990	—
0 (this device)	K972913	Macropore Protective Sheet (Protego System)	Pacific Materials and Interfaces	1998	—
+1	K993061	Stryker Leibinger Resorbable Fixation System	Stryker Instruments	1999	—
+1	K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	—
+2	K060177	KLS Martin Rigid Fixation - Sterile	KLS Martin L.P.	2006	—
+3	K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	—
+4	K151983	KLS Martin LSS Plating System	KLS Martin L.P.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	2	0

Descendants by year cleared

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

FIG. 1 — Lineage of K972913, 1990–2026Source: 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? (5)

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
*	K960988	Lactosorb Trauma Plating System Summary page 3 …each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: LactoSorb Trauma Plating System from W. Lorenz, a unit of Biomet, Inc. (K960988, K955729), Tilghman Titanium Mesh Skeletal Orbit Liner from TiMesh, Inc. (K922308), Motech Titanium Mesh from Biedermann MOTECH G…	Poly-Medics,Inc.	1996	—
*	K955729	Lactosorb Trauma Plating System Summary page 3 …hich has been determined by FDA to be substantially equivalent to pre-amendment devices: LactoSorb Trauma Plating System from W. Lorenz, a unit of Biomet, Inc. (K960988, K955729), Tilghman Titanium Mesh Skeletal Orbit Liner from TiMesh, Inc. (K922308), Motech Titanium Mesh from Biedermann MOTECH GmbH (K900…	Poly-Medics,Inc.	1996	1
*	K922308	Tilghman Titanium Mesh Skeletal Orbit Liner Summary page 3 …ndment devices: LactoSorb Trauma Plating System from W. Lorenz, a unit of Biomet, Inc. (K960988, K955729), Tilghman Titanium Mesh Skeletal Orbit Liner from TiMesh, Inc. (K922308), Motech Titanium Mesh from Biedermann MOTECH GmbH (K900138), and Leibinger Titanium DynamicMesh. Intended Use The indications…	Ti-Mesh, Inc.	1993	—
*	K900138	Motech Titanium Surgical Mesh Summary page 3 …nz, a unit of Biomet, Inc. (K960988, K955729), Tilghman Titanium Mesh Skeletal Orbit Liner from TiMesh, Inc. (K922308), Motech Titanium Mesh from Biedermann MOTECH GmbH (K900138), and Leibinger Titanium DynamicMesh. Intended Use The indications for use of MacroPore Protective Sheet (MPS) are not new indi…	Biedermann Motech GmbH	1990	—
*	—	Leibinger Titanium DynamicMesh Named without a submission number			—

Also cleared against K960988: 4 other devices →

What descends from it? (84)

See all 84

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

Number	Device	Applicant	Decided	Descendants
K993061	Stryker Leibinger Resorbable Fixation System	Stryker Instruments	1999	79
K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	73
K992905	Codman Craniosorb Absorbable Fixation System	Codman & Shurtleff, Inc.	2000	3
K012486	Osteomed Bioresorbable Fixation System	Osteomed Corp.	2002	0
K012413	Macropore FX, PS, NS, LP	Macropore Biosurgery, Inc.	2001	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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K993061 (Stryker Instruments, 1999) has gone furthest, with 79 descendants of its own.
4 other devices also cite its predicate K960988.

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?

MacroPore Protective Sheet (MPS) is intended 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.

The system is not intended for use in the mandible and/or for 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/K972913 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972913: Macropore Protective Sheet (Protego System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972913

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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