The FDA granted De Novo approval to Miach Orthopedics' Bridge-Enhanced ACL Repair (BEAR) implant, a bovine collagen implant placed between torn ACL ends to facilitate natural healing over 8 weeks. A randomized controlled trial of 100 subjects found the BEAR implant patients reported similar knee function scores to ACL reconstruction patients at 2 years. This less invasive option with quicker recovery attracted the NFL Players Association and creates a new regulatory pathway for similar devices.

1. NFL-Supported Medical Device gets FDA De Novo
By: Madison Wheeler
Tears in the anterior cruciate ligament (ACL) are one of the most commonsports injuries every
year. Despite being extremely common, up until recently the only way to treat an ACL tear was
to perform ACL reconstruction, which typically utilizes either allograft or autograft to repair the
tendons. This month, the FDA granted De Novo approval to a synthetic device from Miach
Orthopedics aimed at revolutionizing the way ACL tears are treated.
Miach’s Bridge-Enhanced ACL Repair (BEAR) surgical implant is made from bovine collagen
and is a resorbable implant, meaning it is absorbed by the body.1 The BEAR Implant is surgically
placed between the torn ACL ends and injected with the patient's blood, forming a device-
protected clot that facilitates the body’s natural healing process. After about 8weeks, the
implant is fully absorbed and replaced by the patient’s body tissue. The less invasive treatment
and quicker recovery time made the BEAR Implant extremely attractive to the NFL Players
Association. “ACL injuries are all too common among athletes of all ages and can be a career-
ending injury in the NFL, which is why the NFL Players Association has been a sponsor of the
BEAR clinical trials since the beginning,” said Sean Sansiveri, Vice President of the National
Football League Players Association.2
The FDA assessed the safety and effectiveness of the BEAR implant through a randomized
controlled trial of 100 subjects with complete ACL rupture. 65 subjects received the device and
35 underwent conventional ACL reconstruction, with both groups receiving physical therapy. At
a two-year post-op follow up, patients were assessed using the International Knee
Documentation Committee Subjective Score, a common questionnaire used to report and
standardize knee-treatment outcome data. The patients with the BEAR implant reported an
average score of 88.6 and control subjects reported an average score of 84.6. Using this data, the
FDA assessed the BEAR Implant via the De Novo pathway and granted marketing authorization.
This authorization also comes with special controls, including requirements for labeling and
performance testing, that coupled with general controls provide “reasonable assurance of safety
and effectiveness for devices of this type”3. Additionally, this authorization creates a new
regulatory classification, providing a potential 510(k) pathway for similar devices.
If you need help understanding if your device is suitable for the De Novo pathway, EMMA
International canhelp! Contact us at info@emmainternational.com or call 248-987-4497 to get
connected with our team of regulatory experts today!
1 Miach Orthopedics (n.d.) BEAR Implant retrieved on12/27/2020 from:https://www.miachortho.com/patients/#BEAR
2 BioSpace (Dec 2020) MiachOrthopaedics’ BEARImplant Granted FDA De Novo Approvalfor Treatment ofACL Tears retrieved
on 12/27/2020 from:https://www.biospace.com/article/releases/miach-orthopaedics-bear-implant-granted-fda-de-novo-
approval-for-treatment-of-acl-tears/
3 FDA (Dec 2020) FDA Authorizes Marketing ofNewImplant to Repair a TornACL retrieved on12/27/2020 from:
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-new-implant-repair-torn-acl