Chrysalis Intelligence · Product Codes · OWW

OWW · Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

General, Plastic Surgery · 8 clearances · 6 unique sponsors

Device class
Class II
Regulation 878.3300
Total clearances
8
2021-04-30 → 2025-07-18
Last 12 months
0
Unique sponsors
6
Definition

What is Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Medical specialty
General, Plastic Surgery
Review panel
OR
Regulation number
878.3300
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Conmed Corporation 2 0 2024-11-27
Alafair Biosciences, Inc. 2 0 2025-07-18
International Life Sciences 1 0 2023-05-26
Biorez, Inc. 1 0 2021-04-30
Nanofiber Solutions, LLC 1 0 2025-02-27
Celestray Biotech Company, LLC., 1 0 2023-07-06
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
24341 CPT — Medium Repair, tendon or muscle, upper arm or elbow area; primary, single, each tendon or muscle
28200 CPT — Medium Repair, tendon, flexor, foot; primary or secondary, without free graft, each tendon
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-18 K251655 Alafair Biosciences VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
2025-02-27 K250021 Nanofiber Solutions, LLC Rotium
2024-11-27 K242187 Conmed Corporation BioBrace®
2024-07-29 K241906 Conmed Corporation BioBrace® Reinforced Implant
2024-06-14 K240817 Alafair Biosciences, Inc. VersaWrap
2023-07-06 K222220 Celestray Biotech Company, LLC., SpinMedix Absorbable Fibrous Membrane
2023-05-26 K230316 International Life Sciences FlexBand; FlexPatch; FlexBand Plus
2021-04-30 K203267 Biorez, Inc. The BioBrace Implant