510(k) · Cleared
ClearedCollagen Meniscus Implant XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivy Sports Medicine, LLC · OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Cleared on May 2, 2017 as substantially equivalent to K082079 (Regen Biologics, Inc., 2008) after an 85-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.
- Decided
- May 2, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- OLC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921895 (1992). 55 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 1 generation backK082079 Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
- This deviceK170364 Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017
- Descendant · cites it directly · 0 of its ownK242302 RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 1 generation backK082079 Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
- This deviceK170364 Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −1 | K082079 | Regen Collagen Scaffold (CS) | Regen Biologics, Inc. | 2008 | — |
| 0 (this device) | K170364 | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | 2017 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 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 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
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 |
|---|---|---|---|
| * | K082079 | Regen Collagen Scaffold (CS)Summary page 5…Collagen Meniscus Implant XL Ivy Sports Medicine, LLC Special 510(k) Submission under K082079 (Also known as the ReGen CS and the Ivy Sports Medicine Collagen Meniscus Implant (CMI)). Device Description: The Ivy Sports Me… | 2008 |
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 |
|---|---|---|---|
| K242302 | RejuvaKnee™ Collagen Meniscus Implant | 2024 | 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 25 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 55 ancestors has a recall of any class.
- Of its descendants, K242302 (Collagen Matrix, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLC devicesOLC 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. 2017, this device’s year, is highlighted.
FDA decisions per year · OLC
1in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLC
2in 2019
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 Ivy Sports Medicine Collagen Meniscus Implant (CMI) 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 CMI must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CMI reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CMI 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/K170364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170364: Collagen Meniscus Implant XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170364
Report an extraction error
Are you the manufacturer?
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