De Novo · Granted
GrantedBEAR (Bridge-Enhanced ACL Repair) Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miach Orthopaedics, Inc. · QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Granted on Dec 16, 2020 as a new device type through De Novo after a 195-day review. 2 later devices descend from it.
- Decided
- Dec 16, 2020
- Review
- 195 days
- Class
- Class II
- Product code
- QNI
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN200035 BEAR (Bridge-Enhanced ACL Repair) ImplantMiach Orthopaedics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK243578 BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK251214 BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | Miach Orthopaedics, Inc. | 2020 | — |
| +1 | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2025 | 2 |
| +2 | K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QNI device
- #1 K251214 BEAR® (Bridge-Enhanced ACL Restoration) Implantscore 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243578 (Miach Orthopaedics, Inc., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QNI devicesQNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QNI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNI
Too few QNI 510(k)s in any year since 2007 to give a median.
Recalls per year · QNI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QNI
29in 2025
MAUDE reports naming product code QNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BEAR® (Bridge Enhanced ACL Repair) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200035 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200035: BEAR (Bridge-Enhanced ACL Repair) Implant.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200035
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026