BETA
Bioengineered BEAR implant supporting restoration of a torn anterior cruciate ligament.
Miach Orthopaedics commercializes the Bridge-Enhanced ACL Restoration (BEAR) Implant, a resorbable implant used with a patient’s blood to support healing of the torn ACL. The approach seeks to preserve native ligament tissue rather than replace it with a tendon graft, with patient selection governed by current labeling.
The technology originated in Martha Murray’s research at Boston Children’s Hospital. FDA granted the original De Novo request in December 2020; later 510(k) decisions document updates to the marketed device. The January 2026 record supports updated labeling, and should not be confused with a new De Novo authorization.
The company is based in Westborough, Massachusetts. Jamal Rushdy is its current President and CEO, and Lisa Donnelly is Chief Marketing Officer. Commercial priorities include surgeon education, evidence generation and expansion of access to ACL restoration.
The BEAR Implant has De Novo grant DEN200035 and subsequent 510(k) decisions K243578 and K251214. These establish device-specific authorization and labeling updates, rather than separate products or approval of every ACL-treatment claim. [15][21][19][3][4][2][22][1]
FDA lists two open, lot-specific BEAR recalls: lot 7008409 (action initiated February 2023; posted November 2025) for rapid hydration/integrity concerns, and lot 7011098 (initiated December 2025) for incorrect expiration/UDI labeling. These records concern the specified lots, rather than every BEAR Implant. [9][8]
FDA’s August 19, 2025 warning letter identified quality-system, complaint-handling and medical-device-reporting deficiencies involving BEAR manufacture and postmarket reporting. The letter is separate from the lot-specific recalls and is not itself a withdrawal of the device’s marketing authorization. A subsequent FDA close-out was not located in this review. [22]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Bioengineered resorbable scaffold used with autologous blood during ACL restoration. [15][21][20]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial BEAR program; selected original and subsequent FDA decisions are mapped, rather than treating each update as a separate product. [15][21][19]
FDA recorded clearance of K251214; product labeling and eligibility should be checked in the current IFU. [21]
FDA granted DEN200035 for the original BEAR implant. [19]
Accessed 10/29/2026