Chrysalis Intelligence · Product Codes · QNI

QNI · Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Orthopedic · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 888.3044
Total clearances
3
2020-12-16 → 2026-01-13
Last 12 months
1
Unique sponsors
1
Definition

What is Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3044
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
Miach Orthopaedics, Inc. 3 1 2026-01-13
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
29889 CPT High Arthroscopically visualized knee surgery; with ligament restoration (ACL) with autograft or allograft
29888 CPT Medium Arthroscopically visualized knee surgery; with ligament restoration (ACL) with autograft
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-13 K251214 Miach Orthopaedics, Inc. BEAR® (Bridge-Enhanced ACL Restoration) Implant
2025-03-06 K243578 Miach Orthopaedics, Inc. BEAR® (Bridge-Enhanced ACL Restoration) Implant
2020-12-16 DEN200035 Miach Orthopaedics, Inc. BEAR (Bridge-Enhanced ACL Repair) Implant