510(k) Report

510(k) · Cleared

Cleared

MP 719

K111524510(k) TraditionalCleared Jul 22, 201150-day reviewClass U

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

Marine Polymer Technologies, Inc. · MTJ Wax, Bone

Cleared on Jul 22, 2011 as substantially equivalent to K070557 (Marine Polymer Technologies, Inc., 2007) and 3 other predicates after a 50-day review. Its family tree reaches back 9 generations to 1979.

Decided
Jul 22, 2011
Review
50 days
Class
Class U
Product code
MTJ
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K791495 (1979). 34 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2005: 2 other ancestors2003: 3 other ancestors2002: 3 other ancestors2000: 3 other ancestors1998: 3 other ancestors1996: 1 other ancestor1993: 1 other ancestor1991: 3 other ancestors1988: 1 other ancestor2004: 1 other ancestor1992: 1 other ancestorK791495 · Lukens Bone Wax (Gamma Radiation) · Lukens Corp. · 1979K971680 · Auto Suture Bone Wax · United States Surgical, A Division of Tyco Healthc · 1997K041363 · Aoc Bone Wax · Ceremed, Inc. · 2004 · recalledK050440 · Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 · Ceremed, Inc. · 2005K052528 · Aoc Bone Wax Ostene, Osteotene and Ceretene · Ceremed, Inc. · 2005×2: 2 generations cleared close together, K062280 (2006), K070093 (2007) K082491 · Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene · Ceremed, Inc. · 2008K091636 · Ostene CT, Aoc CT, Osteotene, Ceretene · Ceremed, Inc. · 20091980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 5 other ancestors4 generations back: 7 other ancestors5 generations back: 1 other ancestor6 generations back: 4 other ancestors K091636 · Ostene CT, Aoc CT, Osteotene, Ceretene · Ceremed, Inc. · 2009K082491 · Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene · Ceremed, Inc. · 2008K070093 · Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste · Ceremed, Inc. · 2007K062280 · Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste · Ceremed, Inc. · 2006K052528 · Aoc Bone Wax Ostene, Osteotene and Ceretene · Ceremed, Inc. · 2005K050440 · Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 · Ceremed, Inc. · 2005K041363 · Aoc Bone Wax · Ceremed, Inc. · 2004 · recalledK971680 · Auto Suture Bone Wax · United States Surgical, A Division of Tyco Healthc · 1997K791495 · Lukens Bone Wax (Gamma Radiation) · Lukens Corp. · 1979−50
  1. Root · 9 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
  2. 5 generations between
  3. 3 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
  4. 2 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
  5. 1 generation backK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
  6. This deviceK111524 MP 719Marine Polymer Technologies, Inc. · 2011
Show all 9 generations
  1. Root · 9 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
  2. 8 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
  3. 7 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
  4. 6 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
  5. 5 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
  6. 4 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
  7. 3 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
  8. 2 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
  9. 1 generation backK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
  10. This deviceK111524 MP 719Marine Polymer Technologies, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K791495Lukens Bone Wax (Gamma Radiation)Lukens Corp.1979—
−8K971680Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc1997—
−7K041363Aoc Bone WaxCeremed, Inc.20041
−6K050440Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12Ceremed, Inc.2005—
−5K052528Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc.2005—
−4K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc.2006—
−3K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc.2007—
−2K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene…Ceremed, Inc.2008—
−1K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.2009—
0 (this device)K111524MP 719Marine Polymer Technologies, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199130
199210
199310
199610
199830
200030
200230
200330
200410
200520
200620
200710
FIG. 1 — Lineage of K111524, 1979–2011Source: 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 MTJ? 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 MTJ device

  1. #1 K262769 Permatage XT Settable Nonabsorbable Hemostatic…score 15.5 · 13 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? (4)

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
*K070557MP 719
Summary page 1
…" G. Regulatory Class: Unclassified H. Product Code: MTJ I. Predicate Devices: Marine Polymer Technologies, Inc.- Taliderm (K070557) Ceremed, Inc. Ostene CT Soluble Bone Hemostasis Implant Material (K091 636) Orthocon, Inc. HemaSorbTM Resorbable Hemostati…
Marine Polymer Technologies, Inc.2007—
*K091636Ostene CT, Aoc CT, Osteotene, Ceretene
Summary page 1
…MTJ I. Predicate Devices: Marine Polymer Technologies, Inc.- Taliderm (K070557) Ceremed, Inc. Ostene CT Soluble Bone Hemostasis Implant Material (K091 636) Orthocon, Inc. HemaSorbTM Resorbable Hemostatic Bone Putty (K0633 30) United States Surgical Corporation Bone Wax -( K9716…
Ceremed, Inc.2009—
*K063330Orthocon Hemasorb Resorbable Hemostatic Bone Putty
Summary page 1
…s, Inc.- Taliderm (K070557) Ceremed, Inc. Ostene CT Soluble Bone Hemostasis Implant Material (K091 636) Orthocon, Inc. HemaSorbTM Resorbable Hemostatic Bone Putty (K0633 30) United States Surgical Corporation Bone Wax -( K971680)…
Orthocon, Inc.2006—
*K971680Auto Suture Bone Wax
Summary page 1
…le Bone Hemostasis Implant Material (K091 636) Orthocon, Inc. HemaSorbTM Resorbable Hemostatic Bone Putty (K0633 30) United States Surgical Corporation Bone Wax -( K971680)…
United States Surgical, A Division of Tyco Healthc1997—

Also cleared against K070557: 1 other device →

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 32 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 34 ancestors have a recall of any class.
  • 1 other device also cites its predicate K070557.

How does its category compare?

All MTJ devices

MTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MTJ

4in 2023

2008: 12009: 22010: 12011: 52012: 32013: 22014: 42015: 22016: 22019: 12020: 12021: 12022: 12023: 42026 (partial year): 2
2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MTJ

370in 2023

2011: 140 days median2012: 141 days median2014: 46 days median2023: 370 days median
2007high 370 (2023) · low 46 (2014)2026

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

Recalls per year · MTJ

1in 2023

2008: 12023: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MTJ

22in 2025

2007: 22008: 12011: 22012: 82013: 52014: 62015: 112016: 72017: 72018: 122019: 172020: 162021: 122022: 312023: 202024: 322025: 22
2007high 32 (2024) · low 0 (2009)2025

MAUDE reports naming product code MTJ, 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
20070—02
20081—11
20092—00
20101—00
2011514002
2012314108
20132—05
201444606
20152—011
20162—07
20170—07
20180—012
20191—017
20201—016
20211—012
20221—031
20234370120
20240—032
20250—022
20262—0—

What is it indicated for?

MP719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries.

MP719 is intended for use under the direction of a healthcare professional.

Indications for use as stated in the FDA summary.

Also cleared against K070557

1 other device cites the same predicate.

  • K102002TalymedMarine Polymer Technologies · 2010

More from Marine Polymer Technologies, Inc.

8 FDA decisions under this applicant name. See the company

  • K160695Talymed SuspensionMarine Polymer Technologies, Inc. · 2016
  • K082703MRDH BandageMarine Polymer Technologies, Inc. · 2008
  • K070557MP 719Marine Polymer Technologies, Inc. · 2007
  • K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006
  • K002550RDH BandageMarine Polymer Technologies, Inc. · 2000

Recent decisions in MTJ

The MTJ category page

  • K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc. · 2026
  • K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc. · 2026
  • K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
  • K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
  • K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc. · 2023

https://510kreport.com/device/K111524 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111524: MP 719.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111524

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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