FDA product code OLC: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
OLC is the FDA product code for scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under OLC, 1 in the last five years, from 3 different applicants. The average 510(k) review took 97 days (median 85); 58 days on average over the last three years. FDA has posted 1 recall for OLC devices.
Definition
Intended for use in surgical procedures for the repair and reinforcement 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 must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure.
Classification
| Field | Value |
|---|---|
| Device name | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OLC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 85 |
| 2024 | 1 | 58 |
Compare with all 510(k) review times · Search every OLC clearance
Top OLC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Collagen Matrix, Inc. | 1 | 2024-10-02 |
| Ivy Sports Medicine, LLC | 1 | 2017-05-02 |
| Regen Biologics, Inc. | 1 | 2008-12-18 |
Most recent OLC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242302 | Collagen Matrix, Inc. | RejuvaKnee Collagen Meniscus Implant | 2024-10-02 | 58 |
| K170364 | Ivy Sports Medicine, LLC | Collagen Meniscus Implant XL | 2017-05-02 | 85 |
| K082079 | Regen Biologics, Inc. | REGEN COLLAGEN SCAFFOLD (CS) | 2008-12-18 | 148 |
Recalls for OLC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2018-01-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code OLC?
OLC is the FDA product code for scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel.
What device class is OLC?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLC?
Across 3 cleared submissions the average was 97 days from receipt to decision (median 85).
Which companies have the most OLC clearances?
Collagen Matrix, Inc. (1); Ivy Sports Medicine, LLC (1); Regen Biologics, Inc. (1).
Have OLC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code OLC
- Run a recall and safety report across every OLC manufacturer
- Watch product code OLC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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