510(k) Report

510(k) · Cleared

Cleared

Ebi Lactosorb Graft Containment System

K033918510(k) TraditionalCleared Aug 16, 2004242-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

Ebi, L.P. · HRS Plate, Fixation, Bone

Cleared on Aug 16, 2004 as substantially equivalent to K021164 (Macropore Biosurgery, Inc., 2002) and 5 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.

Decided
Aug 16, 2004
Review
242 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K974017 (1998). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor2008: 1 descendant cleared2005: 1 descendant cleared2018: 1 descendant clearedK974017 · Timesh System · Sofamor Danek USA,Inc. · 1998 · recalledK994158 · Macrosorbos Protective Sheet · Macropore Biosurgery, Inc. · 20001995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K994158 · Macrosorbos Protective Sheet · Macropore Biosurgery, Inc. · 2000K974017 · Timesh System · Sofamor Danek USA,Inc. · 1998 · recalled0
  1. Root · 2 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
  2. 1 generation backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
  3. This deviceK033918 Ebi Lactosorb Graft Containment SystemEbi, L.P. · 2004
  4. Descendant · cites it directly · 1 of its ownK073115 OrthomeshSynthes (Usa) · 2008
  5. Descendant · 2 generations on · 0 of its ownK180821 TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018
  6. Descendant · cites it directly · 0 of its ownK052041 Collagen Bone Healing Protective SheetCollagen Matrix, Inc. · 2005

Most influential descendants

Showing 3 of 3 · See all
  • K073115OrthomeshSynthes (Usa) · 2008 · cites it directly1descendant
  • K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018 · 2 generations on0descendants
  • K052041Collagen Bone Healing Protective SheetCollagen Matrix, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K974017Timesh SystemSofamor Danek USA,Inc.19981
−1K994158Macrosorbos Protective SheetMacropore Biosurgery, Inc.2000—
0 (this device)K033918Ebi Lactosorb Graft Containment SystemEbi, L.P.2004—
+1K073115OrthomeshSynthes (Usa)2008—
+2K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC2018—
+1K052041Collagen Bone Healing Protective SheetCollagen Matrix, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201810
FIG. 1 — Lineage of K033918, 1998–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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? (6)

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
*K021164Macropore OS Trauma
Summary page 1
…Classification Namne/Code: I-RS 3. Predicate or legally marketed devices that are substantially equivalent: * MacroPore OS Trauma System, 1K021164 by MacroPore, Inc. * MacroPore OS Protective Sheet, K994 158 by MacroPore, Inc. *Synthes Resorbable Meshe…
Macropore Biosurgery, Inc.2002—
*K994158Macrosorbos Protective Sheet
Summary page 1
…y marketed devices that are substantially equivalent: * MacroPore OS Trauma System, 1K021164 by MacroPore, Inc. * MacroPore OS Protective Sheet, K994 158 by MacroPore, Inc. *Synthes Resorbable Meshes & Sheets, K(003788 by Synthes (U)SA). *Lorenz LactoSorb Pan…
Macropore Biosurgery, Inc.2000—
*K003788Synthes Resorable Meshes and Sheets
Summary page 2
…re OS Trauma System, K021164 by MacroPore, Inc. * MacroPore OS Protective Sheet, K994158 by MacroPore, Inc. * Synthes Resorbable Meshes & Sheets, K003788 by Synthes (USA). * Lorenz LactoSorb Panels and Fasteners K01 1139 by Biomet, Inc. * Biomet LactoSorb Pan…
Synthes (Usa)2001—
*K011139Lorenz Lactosorb Panels and Fasteners
Summary page 2
…tective Sheet, K994158 by MacroPore, Inc. * Synthes Resorbable Meshes & Sheets, K003788 by Synthes (USA). * Lorenz LactoSorb Panels and Fasteners K01 1139 by Biomet, Inc. * Biomet LactoSorb Panels and Fasteners K984390 by Biomet, Inc. LactoSorb Trauma Platin…
Biomet, Inc.2001—
*K984390Lactosorb Panels and Fasteners
Summary page 2
…shes & Sheets, K003788 by Synthes (USA). * Lorenz LactoSorb Panels and Fasteners K01 1139 by Biomet, Inc. * Biomet LactoSorb Panels and Fasteners K984390 by Biomet, Inc. LactoSorb Trauma Plating System, K992355 by Biomet, Inc.…
Biomet, Inc.2000—
*K992355Lactosorb Trauma Plating System
Summary page 2
…Panels and Fasteners K01 1139 by Biomet, Inc. * Biomet LactoSorb Panels and Fasteners K984390 by Biomet, Inc. LactoSorb Trauma Plating System, K992355 by Biomet, Inc. in Th…
Biomet, Inc.1999—

Also cleared against K021164: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K073115OrthomeshSynthes (Usa)20081
K052041Collagen Bone Healing Protective SheetCollagen Matrix, Inc.20050

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 6 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K073115 (Synthes (Usa), 2008) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K021164.

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

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
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

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The LactoSorb® Graft Containment System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The LactoSorb® Graft Containment System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the LactoSorh® Graft Containment System is intended to maintain the relative…

Read the full statement (161 words)

The LactoSorb® Graft Containment System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The LactoSorb® Graft Containment System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the LactoSorh® Graft Containment System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: long bones, flat bones, short bones, irregular bones, appendicular skeleton, thorax and ribs. When used alone (without traditional rigid fixation), the LactoSorb® Graft Containment System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: tumor resections where bone strength has not been compromised and iliac crest harvests. Tile device is not intended for use in the spine. The device is not intended for load bearing applications unless used in conjunction with traditional rigid fixation.

Indications for use as stated in the FDA summary.

Also cleared against K021164

1 other device cites the same predicate.

  • K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

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https://510kreport.com/device/K033918 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033918: Ebi Lactosorb Graft Containment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033918

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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