510(k) · Cleared

Cleared

Regen Collagen Scaffold (CS)

K082079510(k) TraditionalCleared Dec 18, 2008148-day reviewClass II21 CFR 878.3300

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

Regen Biologics, Inc. · OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Cleared on Dec 18, 2008 as substantially equivalent to K031969 (DePuy Orthopaedics, Inc., 2003) and 20 other predicates after a 148-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it.

Decided: Dec 18, 2008
Review: 148 days
Class: Class II
Product code: OLC
Recalls: None
Predicates: 22

Its longest line of descent runs back 8 generations to K921895 (1992). 54 ancestors in all, the oldest K830889 (1983). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
2 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
1 generation backK051766 OrthomendTei Biosciences, Inc. · 2005
This deviceK082079 Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
Descendant · cites it directly · 1 of its ownK170364 Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017
Descendant · 2 generations on · 0 of its ownK242302 RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all

K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017 · cites it directly1descendant
K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K921895	Tissue Patch, Tissue Graft	Bio-Vascular, Inc.	1992	—
−7	K961810	Supple Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
−6	K980431	Surgisis	Cook Biotech, Inc.	1998	—
−5	K992159	Surgisis Sling	Cook Biotech, Inc.	1999	—
−4	K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	—
−3	K020049	Fortaflex Surgical Mesh	Organogenesis, Inc.	2002	—
−2	K042809	Cuffpatch	Organogenesis, Inc.	2004	—
−1	K051766	Orthomend	Tei Biosciences, Inc.	2005	—
0 (this device)	K082079	Regen Collagen Scaffold (CS)	Regen Biologics, Inc.	2008	—
+1	K170364	Collagen Meniscus Implant XL	Ivy Sports Medicine, LLC	2017	—
+2	K242302	RejuvaKnee™ Collagen Meniscus Implant	Collagen Matrix, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	1	0
1988	1	0
1991	3	0
1992	1	0
1993	1	0
1996	3	0
1997	3	0
1998	6	0
2000	6	0
2001	3	0
2002	3	0
2003	5	0
2004	5	0
2005	3	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2024	1	0

FIG. 1 — Lineage of K082079, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 OLC? 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 OLC device

#1 K242302 RejuvaKnee™ Collagen Meniscus Implantscore 10.8 · 10 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (23)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K031969	Depuy Restore Orthobiologic Soft Tissue Implant Summary page 1 …ation Code: FTM Reviewing Panel: Orthopedic Devices Predicate Devices * Restore Orthobiologic Implant, DePuy Orthopaedics, Inc. (K031969, K001738 and K982330); * SIS Fistula Plug, Cook Biotech, Inc. (K050337); * TissueMend, Orth…	DePuy Orthopaedics, Inc.	2003	—
*	K001738	Depuy Restore Orthobiologic Soft Tissue Implant Summary page 1 …e: FTM Reviewing Panel: Orthopedic Devices Predicate Devices * Restore Orthobiologic Implant, DePuy Orthopaedics, Inc. (K031969, K001738 and K982330); * SIS Fistula Plug, Cook Biotech, Inc. (K050337); * TissueMend, OrthoMend, TE…	DePuy Orthopaedics, Inc.	2000	—
*	K982330	Depuy Orthotech Restore Orthobiologic Soft Tissue Implant Summary page 1 …Reviewing Panel: Orthopedic Devices Predicate Devices * Restore Orthobiologic Implant, DePuy Orthopaedics, Inc. (K031969, K001738 and K982330); * SIS Fistula Plug, Cook Biotech, Inc. (K050337); * TissueMend, OrthoMend, TEI Bioscience…	Depuy, Inc.	1998	—
*	K050337	Sis Fistula Plug Summary page 1 …Restore Orthobiologic Implant, DePuy Orthopaedics, Inc. (K031969, K001738 and K982330); * SIS Fistula Plug, Cook Biotech, Inc. (K050337); * TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Co…	Cook Biotech, Inc.	2005	—
*	K031188	Orthomend Summary page 1 …01738 and K982330); * SIS Fistula Plug, Cook Biotech, Inc. (K050337); * TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * B…	Tei Biosciences, Inc.	2003	—
*	K051766	Orthomend Summary page 1 …82330); * SIS Fistula Plug, Cook Biotech, Inc. (K050337); * TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Su…	Tei Biosciences, Inc.	2005	—
Kept off the family tree	K974540	FDA’s K974540 is Sis Hernia Repair Device Our reading of the summary gave K974540, FDA’s number for Sis Hernia Repair Device (Sentron Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Surgisis Mesh”. Kept off the family tree. Summary page 1 …(K050337); * TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923);…	Sentron Medical, Inc.	1998	—
*	K980431	Surgisis Summary page 1 …; * TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); *…	Cook Biotech, Inc.	1998	—
*	K992159	Surgisis Sling Summary page 1 …* TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patc…	Cook Biotech, Inc.	1999	—
*	K034039	Sis Plastic Surgery Matrix Summary page 1 …ssueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766); * Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permac…	Cook Biotech, Inc.	2004	—
*	K043259	Bioblanket Surgical Mesh Summary page 1 …* Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K04336…	Kensey Nash Corp.	2005	—
*	K041923	Bioblanket Summary page 1 …rgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039); * BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355);…	Kensey Nash Corp.	2004	—
*	K992556	Permacol Summary page 1 …BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and…	Tissue Science Laboratories, Plc	2000	—
*	K013625	Permacol Summary page 1 …Blanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673)…	Tissue Science Laboratories, Plc	2002	—
*	K021056	Permacol Summary page 1 …urgical Mesh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673);…	Tissue Science Laboratories, Plc	2002	—
*	K043366	Permacol Surgical Implant Summary page 1 …esh, Kensey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673); * S…	Tissue Science Laboratories, Plc	2004	—
*	K050355	Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models… Summary page 1 …ey Nash, Corp. (K043259 and K041923); * ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673); * SIS Plasti…	Tissue Science Laboratories, Plc	2005	—
*	K024199	Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L… Summary page 2 …sue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673); * SIS Plastic Surgery Matrix, Cook Biotech, Inc. (K034039) * Sportmesh, A…	Osteobiologics, Inc.	2003	—
*	K032673	Immix Plastifilm Summary page 2 …Laboratories PLC (K992556, K013625, K021056, K043366, K050355); * IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673); * SIS Plastic Surgery Matrix, Cook Biotech, Inc. (K034039) * Sportmesh, Artimplant (K…	Osteobiologics, Inc.	2003	—
*	K052830	Sportmesh Summary page 2 …Inc. (K024199 and K032673); * SIS Plastic Surgery Matrix, Cook Biotech, Inc. (K034039) * Sportmesh, Artimplant (K052830) * Optimesh, Spineology, Inc. (K014200) * Marlex Mesh, Davol, Inc. (Pre-amendment). Device Descript…	Artimplant AB	2006	—
*	K014200	Optimesh Summary page 2 …SIS Plastic Surgery Matrix, Cook Biotech, Inc. (K034039) * Sportmesh, Artimplant (K052830) * Optimesh, Spineology, Inc. (K014200) * Marlex Mesh, Davol, Inc. (Pre-amendment). Device Description The ReGen Collagen Scaffold (CS) is a resorbable…	Spineology, Inc.	2003	—
*	K042809	Cuffpatch Summary page 2 …TM Surgical Mesh (K043259, K041923), the Tissue Sciences Laboratories' Permacol and ZCR Patch (K992556, K013625, K021056, K043366, K050355), the Organogenesis CuffPatch (K042809), the Cook Biotech SIS Plastic Surgery Matrix (K034039), the Artimplant Sportmesh (K052830) and the Spineology Optimesh (K014200)…	Organogenesis, Inc.	2004	—
*	—	Marlex Mesh Named without a submission number			—

Also cleared against K031969: 7 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K170364	Collagen Meniscus Implant XL	Ivy Sports Medicine, LLC	2017	1

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 16 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
1 of the 54 ancestors has a recall of any class.
Of its descendants, K170364 (Ivy Sports Medicine, LLC, 2017) has gone furthest, with 1 descendant of its own.
7 other devices also cite its predicate K031969.

How does its category compare?

All OLC devices

OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OLC

1in 2024

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLC

Too few OLC 510(k)s in any year since 2007 to give a median.

Recalls per year · OLC

1in 2018

2007high 1 (2018) · low 0 (2007)2026

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

Adverse event reports per year · OLC

2in 2019

2007high 2 (2010) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	1	—	0	0
2009	0	—	0	0
2010	0	—	0	2
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	1	—	0	1
2018	0	—	1	1
2019	0	—	0	2
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	1	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The ReGen Collagen Scaffold (CS) Is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

The CS reinforces soft tissue and provides a resorbabkescaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082079 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082079: Regen Collagen Scaffold (CS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082079

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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