510(k) · Cleared
Recalled · Class II · 2025BEAR® (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 Mar 6, 2025 as substantially equivalent to DEN200035 (Miach Orthopaedics, Inc., 2020) after a 107-day review. Its family tree reaches back 1 generation to 2020. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 6, 2025
- Review
- 107 days
- Class
- Class II
- Product code
- QNI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200035 (2020). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN200035 BEAR (Bridge-Enhanced ACL Repair) ImplantMiach Orthopaedics, Inc. · 2020
- This deviceK243578 BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251214 BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251214BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | Miach Orthopaedics, Inc. | 2020 | — |
| 0 (this device) | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2025 | — |
| +1 | K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K251214 BEAR® (Bridge-Enhanced ACL Restoration) Implantscore 11.0 · 2 generations · 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 |
|---|---|---|---|
| * | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) ImplantSummary page 5…III. Predicate Device Predicate Manufacturer: Miach Orthopaedics, Inc. Predicate Trade Name: BEAR® (Bridge-Enhanced ACL Restoration) Implant Predicate 510(k) No.: DEN200035 IV. Device Description The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprise… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2025 | Class II | Z-1220-2026 | Process control | Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect. |
| Feb 2, 2023 | Class II | Z-0479-2026 | Under Investigation by firm | The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K251214 (Miach Orthopaedics, Inc., 2026) has gone furthest, with 0 descendants 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. 2025, 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/K243578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243578: 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/K243578
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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