510(k) · Cleared
ClearedBEAR® (Bridge-Enhanced ACL Restoration) 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
Cleared on Jan 13, 2026 as substantially equivalent to K243578 (Miach Orthopaedics, Inc., 2025) after a 270-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Jan 13, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- QNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200035 (2020). No later device cites it as a predicate yet.
- Root · 2 generations backDEN200035 BEAR (Bridge-Enhanced ACL Repair) ImplantMiach Orthopaedics, Inc. · 2020
- 1 generation backK243578 BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2025 · Recalled
- This deviceK251214 BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | Miach Orthopaedics, Inc. | 2020 | — |
| −1 | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2025 | 2 |
| 0 (this device) | K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2026 | — |
Sources: FDA 510(k) 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 K243578 BEAR® (Bridge-Enhanced ACL Restoration) Implantscore 10.0 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) ImplantSummary page 5…III. Predicate Device Predicate Manufacturer: Miach Orthopaedics, Inc. Predicate Trade Name: BEAR® (Bridge-Enhanced ACL Restoration) Implant Predicate 510(k) No.: K243578 IV. Device Description The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprise… | 2025 |
| † | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2026, 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 Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251214: BEAR® (Bridge-Enhanced ACL Restoration) Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251214
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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