Chrysalis Intelligence · Product Codes · OWY

OWY · Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

General, Plastic Surgery · 9 clearances · 6 unique sponsors

Device class
Class II
Regulation 878.3300
Total clearances
9
2020-10-19 → 2025-09-30
Last 12 months
0
Unique sponsors
6
Definition

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

For reinforcement of soft tissue where weakness exists in tendon repair.
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
Embody, Inc. 4 0 2025-09-19
Smith & Nephew Inc., Endoscopy Div. 1 0 2024-11-26
Arthrex, Inc. 1 0 2025-09-30
Tybr Health 1 0 2025-06-06
Smith and Nephew, Inc. 1 0 2023-05-11
Kerecis Limited 1 0 2025-06-04
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
2025-09-30 K251690 Arthrex, Inc. Arthrex SpeedFLEX™ Implant
2025-09-19 K252647 Embody, Inc. Tapestry Biointegrative Implant
2025-06-06 K250109 Tybr Health TYBR Collagen Gel
2025-06-04 K243843 Kerecis Limited Tendon Protect (50242)
2024-11-26 K242631 Smith & Nephew Inc., Endoscopy Div. REGENETEN™ Bioinductive Implant
2023-05-11 K222501 Smith and Nephew, Inc. Regeneten Bioinductive Implant
2022-05-23 K220867 Embody, Inc. Tapestry Biointegrative Implant
2021-11-02 K212306 Embody, Inc. Tapestry Biointegrative Implant
2020-10-19 K201572 Embody, Inc. TAPESTRY Biointegrative Implant