510(k) Report

510(k) · Cleared

Cleared

Macropore Protective Sheet

K983360510(k) TraditionalCleared Mar 19, 1999176-day reviewClass II21 CFR 872.4760

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 · JEY Plate, Bone

Cleared on Mar 19, 1999 as substantially equivalent to K862532 (Walter Lorenz Surgical, Inc., 1986) and 2 other predicates after a 176-day review. Its family tree reaches back 1 generation to 1986. 6 later devices descend from it.

Decided
Mar 19, 1999
Review
176 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K862532 (1986). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 1 other ancestor2002: 1 descendant cleared2007: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant clearedReference device: K972913 · Macropore Protective Sheet (Protego System) · Pacific Materials and Interfaces · 1998K862532 · Dumbach Titanium Mesh Implant System · Walter Lorenz Surgical, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K862532 · Dumbach Titanium Mesh Implant System · Walter Lorenz Surgical, Inc. · 19860
  1. Root · 1 generation backK862532 Dumbach Titanium Mesh Implant SystemWalter Lorenz Surgical, Inc. · 1986
  2. This deviceK983360 Macropore Protective SheetPacific Materials and Interfaces · 1999
  3. Descendant · cites it directly · 5 of its ownK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
  4. Descendant · 2 generations on · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
  5. Descendant · 3 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  6. Descendant · 4 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
  7. Descendant · 4 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12007: 12008: 12010: 12013: 1
2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002 · cites it directly5descendants
  • K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · 2 generations on3descendants
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 3 generations on2descendants
  • K121606Resorb-X GKLS-Martin L.P. · 2013 · 4 generations on0descendants
  • K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K862532Dumbach Titanium Mesh Implant SystemWalter Lorenz Surgical, Inc.1986—
0 (this device)K983360Macropore Protective SheetPacific Materials and Interfaces1999—
+1K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.2002—
+2K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2007—
+3K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2008—
+4K121606Resorb-X GKLS-Martin L.P.2013—
+4K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200710
200810
201010
201310
FIG. 1 — Lineage of K983360, 1986–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JEY? 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 JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K862532Dumbach Titanium Mesh Implant System
Summary page 4
…th the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices: Micro Titanium Augmentation Mesh (M-TAM™) (K862532) from Leibinger, Lactosorb Panels and Fasteners (K980927) from Biomet and Titanium Ridge Augmentation Material (TRAM) (K963394) f…
Walter Lorenz Surgical, Inc.1986—
*K980927Lactosorb Panels and Fasteners
Summary page 4
…mined by FDA to be substantially equivalent to pre-amendment devices: Micro Titanium Augmentation Mesh (M-TAM™) (K862532) from Leibinger, Lactosorb Panels and Fasteners (K980927) from Biomet and Titanium Ridge Augmentation Material (TRAM) (K963394) from Osteomed. Intended Use The intended uses of MacroPo…
Biomet, Inc.19981
*K963394Osteomed Tram
Summary page 4
…Micro Titanium Augmentation Mesh (M-TAM™) (K862532) from Leibinger, Lactosorb Panels and Fasteners (K980927) from Biomet and Titanium Ridge Augmentation Material (TRAM) (K963394) from Osteomed. Intended Use The intended uses of MacroPore Protective Sheet (MPS) are not new in that they are the same as or…
Osteomed Corp.1996—
†K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces1998—

Also cleared against K862532: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025

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 3 ancestors has a recall of any class.
  • Of its descendants, K011569 (Bionx Implants, Inc., 2002) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K862532.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

What is it indicated for?

MacroPore Protective Sheet is intended to facilitate healing in trauma, reconstruction and bone augmentation procedures of the mandible. The following specific indications are included:

= to maintain the relative position of bony fragments in trauma and bone graft procedures, and

« to contain and prevent migration and shifting of autograft, allograft and/or bone graft substitutes that may be necessary in reconstructive procedures.

The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.

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

Also cleared against K862532

2 other devices cite the same predicate.

  • K022185Universal CMF SystemStryker Instruments · 2002
  • K970841Imtec/Titanium MeshImtec Corp. · 1997

More from Pacific Materials and Interfaces

3 FDA decisions under this applicant name. See the company

  • K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
  • K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K983360 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983360: Macropore Protective Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983360

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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