COMPANY
CONMED
Timeline
- FDA FDA 510(k) clearance: Y-Knotless Flex Anchors — K253763, Jan 29, 2026. Applicant at approval: Conmed Corporation. source ↗
- FDA FDA 510(k) clearance: BioBrace® Extra-Articular Ligament Augmentation Kit — K252946, Oct 15, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA FDA 510(k) clearance: CONMED Argo Knotless® Anchor — K251530, Jun 18, 2025. Applicant at approval: Conmed Corporation. source ↗
- Trial start —: BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures source ↗
- FDA FDA 510(k) clearance: BioBrace ® RC Delivery System — K250395, Apr 7, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA FDA 510(k) clearance: Argo Knotless GENESYS Anchor — K244025, Jan 28, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA FDA 510(k) clearance: BioBrace® — K242187, Nov 27, 2024. Applicant at approval: Conmed Corporation. source ↗
- Trial start Not phased (device or behavioral study): BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Not phased · BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears · NCT05997381
- 2030-06 (ESTIMATED) · · BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures · NCT06948591
Clinical trials (lead sponsor) 2
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05997381 | BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears | Not phased (device or behavioral study) | Recruiting | Jan 5, 2024 | 2026-12 (estimated) |
| NCT06948591 | BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures | Not listed | Recruiting | Apr 8, 2025 | 2030-06 (estimated) |
FDA records (last 2 years)
- FDA 510(k) clearance: Y-Knotless Flex Anchors — K253763, Jan 29, 2026. Applicant at approval: Conmed Corporation. source ↗
- FDA 510(k) clearance: BioBrace® Extra-Articular Ligament Augmentation Kit — K252946, Oct 15, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA 510(k) clearance: CONMED Argo Knotless® Anchor — K251530, Jun 18, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA 510(k) clearance: BioBrace ® RC Delivery System — K250395, Apr 7, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA 510(k) clearance: Argo Knotless GENESYS Anchor — K244025, Jan 28, 2025. Applicant at approval: Conmed Corporation. source ↗
- FDA 510(k) clearance: BioBrace® — K242187, Nov 27, 2024. Applicant at approval: Conmed Corporation. source ↗