BEAR Implant (Bridge-Enhanced ACL Restoration)

Primary DI
00860002987804
Brand
BEAR Implant (Bridge-Enhanced ACL Restoration)
Company
Miach Orthopaedics, Inc.
Model
1000
Device description
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.
Published
2021-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNIResorbable Implant For Anterior Cruciate Ligament (Acl) RepairOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200035000BEAR (Bridge-Enhanced ACL Repair) ImplantMiach Orthopaedics, Inc.2020-12-16QNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002987804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002987804008600029878048600029878040860002987804

GMDN Terms#

Term, Definition table
TermDefinition
Cartilage biomatrix implantA sterile, bioabsorbable device intended to be implanted in the void of a cartilage defect of a joint (e.g., knee, ankle, shoulder), typically up to a diameter of 34 mm, during an orthopaedic or traumatologic intervention, to promote the ingrowth of autologous cells (e.g., with bone marrow stimulation techniques) for cartilage reconstruction or augmentation. It consists primarily of an animal-derived matrix structure (e.g., made of animal-derived type 1 collagen, chitosan) that provides a scaffold for cell growth. It is available in various dimensions or may be an injectable fluid, and can be applied arthroscopically, or with miniarthrotomy for larger defects.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016027522
Device count
1
Lot or batch
true
Expiration date on label
true