510(k) Report

510(k) · Cleared

Cleared

Synovis Collagen Matrix (TBD)

K122306510(k) TraditionalCleared Mar 8, 2013219-day reviewClass II21 CFR 870.3470

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

Synovis Surgical Innovations · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Mar 8, 2013 as substantially equivalent to K002233 (Bio-Vascular, Inc., 2000) and 12 other predicates after a 219-day review. Its family tree reaches back 9 generations to 1985.

Decided
Mar 8, 2013
Review
219 days
Class
Class II
Product code
DXZ
Recalls
None
Predicates
13

Its longest line of descent runs back 9 generations to K842066 (1985). 51 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2003: 3 other ancestors2000: 5 other ancestors1998: 2 other ancestors1996: 4 other ancestors1992: 3 other ancestors1983: 2 other ancestors1982: 1 other ancestor2004: 3 other ancestors2002: 2 other ancestors2001: 5 other ancestors1999: 3 other ancestors1997: 3 other ancestors1981: 1 other ancestor1993: 1 other ancestor1994: 2 other ancestorsK842066 · Peri-Guard Pericardial Patch · Genetic Laboratories, Inc. · 1985K961811 · Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K983162 · Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc · Bio-Vascular, Inc. · 1998 · recalledK992537 · Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated · Bio-Vascular, Inc. · 2000K014183 · Afb (Absorbable Foam Buttress) · J&J Corporate Biomaterials Center · 2002K030782 · Seamguard Bioabsorbable Staple Line Reinforcement Material · W. L. Gore & Associates, Inc. · 2003×2: 2 generations cleared close together, K032865 (2003), K040119 (2004) K062915 · Veritas Collagen Matrix · Synovis Surgical Innovations · 2006 · recalled19801985199019952000200520102015
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 10 other ancestors3 generations back: 9 other ancestors4 generations back: 4 other ancestors5 generations back: 3 other ancestors6 generations back: 7 other ancestors K062915 · Veritas Collagen Matrix · Synovis Surgical Innovations · 2006 · recalledK040119 · Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration · Synovis Surgical Innovations · 2004K032865 · Gore Seamguard Bioabsorbable Staple Line Reinforcement Material · W. L. Gore & Associates, Inc. · 2003K030782 · Seamguard Bioabsorbable Staple Line Reinforcement Material · W. L. Gore & Associates, Inc. · 2003K014183 · Afb (Absorbable Foam Buttress) · J&J Corporate Biomaterials Center · 2002K992537 · Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated · Bio-Vascular, Inc. · 2000K983162 · Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc · Bio-Vascular, Inc. · 1998 · recalledK961811 · Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K842066 · Peri-Guard Pericardial Patch · Genetic Laboratories, Inc. · 1985−50
  1. Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
  2. 5 generations between
  3. 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  4. 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
  5. 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
  6. This deviceK122306 Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
Show all 9 generations
  1. Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
  2. 8 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 7 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
  4. 6 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
  5. 5 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
  6. 4 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  7. 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
  8. 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
  9. 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
  10. This deviceK122306 Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K842066Peri-Guard Pericardial PatchGenetic Laboratories, Inc.1985—
−8K961811Peri-Guard PericardiumBio-Vascular, Inc.1996—
−7K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.19982
−6K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated…Bio-Vascular, Inc.2000—
−5K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002—
−4K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
−3K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003—
−2K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple…Synovis Surgical Innovations2004—
−1K062915Veritas Collagen MatrixSynovis Surgical Innovations20061
0 (this device)K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198210
198320
199230
199310
199420
199640
199730
199820
199930
200050
200150
200220
200330
200430
200520
FIG. 1 — Lineage of K122306, 1985–2013Source: 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 DXZ? 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 DXZ device

  1. #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (13)

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
*K002233Bvi Sling
Summary page 1
…polypropylene, polyethylene terephthalate or polytetrafluoroethylene Product Code: DXZ Predicate Devices: " Synovis Surgical Innovations, VeritasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961…
Bio-Vascular, Inc.20001
*K030879Veritas Collagen Matrix
Summary page 1
…ylene, polyethylene terephthalate or polytetrafluoroethylene Product Code: DXZ Predicate Devices: " Synovis Surgical Innovations, VeritasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983…
Synovis Surgical Innovations2003—
*K062915Veritas Collagen Matrix
Summary page 1
…lyethylene terephthalate or polytetrafluoroethylene Product Code: DXZ Predicate Devices: " Synovis Surgical Innovations, VeritasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Syn…
Synovis Surgical Innovations20061
*K921895Tissue Patch, Tissue Graft
Summary page 1
…s Surgical Innovations, VeritasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K18…
Bio-Vascular, Inc.1992—
*K923657Supple Peri-Guard
Summary page 1
…l Innovations, VeritasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K19…
Bio-Vascular, Inc.1992—
*K961810Supple Peri-Guard Pericardium
Summary page 1
…ions, VeritasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K19…
Bio-Vascular, Inc.1996—
*K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…
Summary page 1
…itasO Collagen Matrix: 1(002233, K030879, K062915 * Synovis Surgical Innovations, Supple Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K1971726,K19…
Bio-Vascular, Inc.19982
*K821532Periguard Pericardial Patch
Summary page 1
…e Peni-Guard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K1971726,K1983162 *CorMatrix Cardiovascular Inc, CorMatrix® ECMM for Pericardial Closure:* K(05 14…
Genetic Laboratories, Inc.1982—
*K833021Peri-Guard Pericardial Patch-Hernia
Summary page 1
…ard® Pericardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K1971726,K1983162 *CorMatrix Cardiovascular Inc, CorMatrix® ECMM for Pericardial Closure:* K(05 1405 === P…
Genetic1983—
*K842066Peri-Guard Pericardial Patch
Summary page 1
…cardium with APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K1971726,K1983162 *CorMatrix Cardiovascular Inc, CorMatrix® ECMM for Pericardial Closure:* K(05 1405…
Genetic Laboratories, Inc.1985—
*K961811Peri-Guard Pericardium
Summary page 1
…ith APEX Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K1971726,K1983162 *CorMatrix Cardiovascular Inc, CorMatrix® ECMM for Pericardial Closure:* K(05 1405 Device D…
Bio-Vascular, Inc.1996—
*K971726CV Peri-Guard - Cardiovascular Patch
Summary page 1
…Processing: 1(921895,K1923657,K1961810,K1983162 * Synovis Surgical Innovations, Peni-Guard® Pericardium with APEX Processing: 1(821532,K1833021,K1842066,K1961811,K1971726,K1983162 *CorMatrix Cardiovascular Inc, CorMatrix® ECMM for Pericardial Closure:* K(05 1405 Device Descriptio…
Bio-Vascular, Inc.1998—
*K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.2005—

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 28 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
  • 7 of the 51 ancestors have a recall of any class.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DXZ

1in 2025

2007: 12008: 22009: 12010: 32011: 22012: 12013: 12014: 32015: 22016: 22017: 12020: 12025: 1
2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2010: 91 days median2014: 106 days median
2007high 106 (2014) · low 91 (2010)2026

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

Recalls per year · DXZ

2in 2025

2010: 22011: 22013: 22018: 12020: 12023: 22025: 2, 2 Class I2026 (partial year): 1
2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007: 502008: 62009: 1092010: 812011: 472012: 212013: 692014: 932015: 1712016: 662017: 302018: 442019: 552020: 1212021: 802022: 772023: 402024: 492025: 119
2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, 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
20071—050
20082—06
20091—0109
2010391281
20112—247
20121—021
20131—269
20143106093
20152—0171
20162—066
20171—030
20180—144
20190—055
20201—1121
20210—080
20220—077
20230—240
20240—049
20251—2 (2)119
20260—1—

What is it indicated for?

Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

Indications for use as stated in the FDA summary.

More from Synovis Surgical Innovations

15 FDA decisions under this applicant name. See the company

  • K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 20061 recall
  • K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 20048 recalls
  • K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line…Synovis Surgical Innovations · 20041 recall
  • K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip…Synovis Surgical Innovations · 2004

Recent decisions in DXZ

The DXZ category page

  • K240775PeriBeam® Pericardial MembraneTamabio · 2025
  • K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. · 2020
  • K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K162579VascuCelAdmedus Regen Pty, Ltd. · 2016
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

https://510kreport.com/device/K122306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122306: Synovis Collagen Matrix (TBD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122306

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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