Device class
Class II
Regulation 878.3300
Total clearances
5
2023-08-17 → 2026-01-02
Definition
What is Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
For reinforcement of soft tissue where weakness exists in tendon repair.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.3300
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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.
| Code | Type | Description | Confidence | Rationale |
| 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
| Date | K-number | Sponsor | Device |
|---|
| 2026-01-02 |
K253867 |
ZuriMED Technologies AG
|
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit |
| 2025-06-17 |
K250997 |
Anika Therapeutics, Inc.
|
Integrity Implant |
| 2025-05-29 |
K243480 |
Arthrex, Inc.
|
SuturePatch Tissue Reinforcement |
| 2024-12-11 |
K241219 |
ZuriMED Technologies AG
|
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) |
| 2023-08-17 |
K223538 |
Anika Therapeutics, Inc.
|
Integrity Implant |