510(k) · Cleared
ClearedBiodesign Staple Line Reinforcement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Cleared on Apr 28, 2017 as substantially equivalent to K070405 (Cook Biotech, Inc., 2007) after a 29-day review. Its family tree reaches back 10 generations to 1985. 1 later device descends from it.
- Decided
- Apr 28, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- OXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K842066 (1985). 30 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations between
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK051048 Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005
- 1 generation backK070405 Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007
- This deviceK170945 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK201000 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2020
Show all 10 generations
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 7 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 6 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 5 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK051048 Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005
- 1 generation backK070405 Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007
- This deviceK170945 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017
Most influential descendants
Showing 1 of 1 · See all- K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −9 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −7 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −6 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −5 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −2 | K051048 | Surgisis Staple Line Reinforcement II | Cook Biotech, Inc. | 2005 | — |
| −1 | K070405 | Modification to Surgisis SLR Staple Line Reinforcement | Cook Biotech, Inc. | 2007 | — |
| 0 (this device) | K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2017 | — |
| +1 | K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 OXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K070405 | Modification to Surgisis SLR Staple Line ReinforcementSummary page 4…duct Code: FTM (21 CFR §878.3300) , OXE Regulatory Class: Class II III. PREDICATE DEVICE SURGISIS® SLRTM Staple Line Reinforcement (K070405, Cook Biotech Incorporated) IV. DEVICE DESCRIPTION The Biodesign® Staple Line Reinforcement device is part of a family of impla… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201000 | Biodesign Staple Line Reinforcement | 2020 | 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?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K201000 (Cook Biotech Incorporated, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OXE devicesOXE Mesh, Surgical, Collagen, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OXE
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OXE
Too few OXE 510(k)s in any year since 2007 to give a median.
Recalls per year · OXE
No recall names OXE since 2007.
Adverse event reports per year · OXE
No MAUDE report names OXE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SURGISIS SLR Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g. wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can…
Read the full statement (108 words)
The SURGISIS SLR Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g. wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170945: Biodesign Staple Line Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170945
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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