BEAR® (Bridge-Enhanced ACL Restoration) Implant

K243578 · Miach Orthopaedics, Inc. · QNI · Mar 6, 2025 · Orthopedic

Device Facts

• Record ID: K243578
• Device Name: BEAR® (Bridge-Enhanced ACL Restoration) Implant
• Applicant: Miach Orthopaedics, Inc.
• Product Code: QNI · Orthopedic
• Decision Date: Mar 6, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3044
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

BEAR® Implant is a cylindrical, bovine-derived collagen/extracellular matrix scaffold (22mm x 44mm). Used during ACL repair surgery; surgeon combines implant with up to 10ml of patient's autologous blood. Implant stabilizes blood clot between torn ligament ends; resorbs within 8 weeks; replaced by fibrovascular repair tissue. Used in clinical settings by orthopedic surgeons. Output is a biological scaffold facilitating natural ligament healing. Benefits include restoration of ACL without requiring autograft harvest.

Clinical Evidence

Confirmatory clinical data from prospective multicenter BEAR III study (n=151) and BRIDGE Registry. Primary endpoints: IKDC Subjective Knee Evaluation and IKDC Objective Physical Exam at 2 years. Results showed non-inferior outcomes for patients <14 years vs ≥14 years and no difference in safety/effectiveness between partial and complete ACL tears. AE rates in children <14 were similar to adults.

Technological Characteristics

Bovine-derived Type 1 collagen and extracellular matrix. Cylindrical form factor (22mm diameter, 44mm length). Resorbable. Terminally sterilized via electron-beam irradiation. No electronic or software components.

Indications for Use

Indicated for adults, adolescents, and children with complete or partial ACL rupture confirmed by MRI. Requires ACL stump attached to tibia. Children with open physes must have sufficient epiphyseal bone to avoid growth plate disruption.

Regulatory Classification

Identification

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.

Special Controls

In combination with the general controls of the FD&C Act, the resorbable implant for ACL repair is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Post-operative evaluation of knee pain and function; and (ii) Durability as assessed by re-tear or re-operation rate. (2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Device performance characteristics, including resorption and ligament healing at repair site; and (ii) Adverse effects as assessed by gross necropsy and histopathology. (3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Characterization of materials, including chemical composition, resorption profile, and mechanical properties; and (ii) Simulated use testing, including device preparation, device handling, compatibility with other ACL repair instrumentation, and user interface. (4) The device must be demonstrated to be biocompatible. (5) Performance data must demonstrate the device to be sterile and non-pyrogenic. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Labeling must include the following: (i) Identification of device materials and specifications; (ii) A summary of the clinical performance testing conducted with the device; (iii) Instructions for use, including compatibility with other ACL repair instrumentation or devices; (iv) Warnings regarding post-operative rehabilitation requirements; and (v) A shelf life.

Predicate Devices

• BEAR® (Bridge-Enhanced ACL Restoration) Implant (DEN200035)

Submission Summary (Full Text)

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March 6, 2025

Miach Orthopaedics, Inc. % Julie Broderick Regulatory Consultant Broderick Regulatory Consulting, LLC 7 Kendall Street Winchester, Massachusetts 01890

Re: K243578

Trade/Device Name: BEAR® (Bridge-Enhanced ACL Restoration) Implant Regulation Number: 21 CFR 888.3044 Regulation Name: Resorbable Implant For Anterior Cruciate Ligament (ACL) Repair Regulatory Class: Class II Product Code: QNI Dated: February 5, 2025 Received: February 5, 2025

Dear Julie Broderick:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# CHRISTOPHER EERREIRA -S

Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K243578

Device Name

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Indications for Use (Describe)

The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagenbased 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

#### Submitter Information l.

- Company: Miach Orthopaedics, Inc. 69 Milk Street, Suite 100 Westborough, MA 01581 USA Phone No.: 800-590-6995 Fax No.: 508-986-9625
- Contact: Rita Paparazzo VP, Regulatory, Clinical Operations, Quality and Medical Education Miach Orthopaedics, Inc. Phone No.: 800-590-6995 Email: [e-mail]

Date Prepared: 5 February 2025

#### II. Name of Device

| Device Trade Name: | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
|-----------------------|----------------------------------------------------------------|
| Classification Name: | Resorbable implant for anterior cruciate ligament (ACL) repair |
| Product Code: | QNI |
| Regulation Number: | 21 CFR 888.3044 |
| Device Class: | II |
| Panel Identification: | Orthopedics |

#### 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 comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the tom ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.

Children with open physes must have sufficient bone in the femoral and tibial epiphyses to accommodate a 2.4 mm cannulated drill pin with at least 2-3 mm of bone on either side of the intended tunnel locations to avoid disruption of the growth plates.

#### V. Indications for Use

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,

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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.

| Characteristic | New Device<br>BEAR Implant | Predicate Device*<br>BEAR Implant<br>DEN200035 | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Miach Orthopaedics, Inc. | Miach Orthopaedics, Inc. | Same |
| Regulation No. | 21 CFR 888.3044 | 21 CFR 888.3044 | Same |
| Regulation Name | Resorbable implant for anterior<br>cruciate ligament (ACL) repair | Resorbable implant for anterior<br>cruciate ligament (ACL) repair | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Classification Code | QNI | QNI | Same |
| Intended Use / Indications for<br>Use | The BEAR® (Bridge-Enhanced ACL<br>Restoration) Implant is a bovine<br>extracellular matrix collagen-based<br>implant for treatment of anterior<br>cruciate ligament (ACL) injuries.<br>The BEAR® Implant is indicated for<br>adults, adolescents and children<br>with a complete or partial rupture<br>of the ACL, as confirmed by MRI.<br>Patients must have an ACL stump<br>attached to the tibia to construct<br>the repair. Children with open<br>physes must have sufficient bone<br>in the femoral and tibial epiphyses<br>on either side of the intended<br>tunnel locations to avoid<br>disruption of the growth plates. | The BEAR® (Bridge-Enhanced<br>ACL Restoration) Implant is a<br>bovine extracellular matrix<br>collagen-based implant for<br>treatment of anterior cruciate<br>ligament (ACL) injuries. The<br>BEAR® Implant is indicated for<br>skeletally-mature patients at<br>least 14 years of age with a<br>complete rupture of the ACL, as<br>confirmed by MRI. Patients<br>must have an ACL stump<br>attached to the tibia to<br>construct the repair. | Same except for changes in<br>Indications:<br>Remove age limitation<br>-<br>(≥14 years)<br>Remove requirement for<br>-<br>patient to be skeletally<br>mature<br>Replace both with "adults,<br>adolescents and children"<br>Add requirement for<br>epiphyseal bone in<br>children to avoid<br>disruption of growth<br>plates<br>Add partial rupture of ACL<br>-<br>Same Intended Use; both new<br>and predicate devices are<br>intended for use in treating<br>ACL injuries. |
| Device Description | The BEAR Implant (22 mm in<br>diameter and 44mm in length) is<br>cylindrical in shape and comprised<br>of collagen and extracellular<br>matrix derived from bovine<br>connective tissue, which has been<br>cleaned, disinfected and processed<br>by a proprietary manufacturing<br>method. The implant is intended<br>to be used with up to 10 ml of<br>autologous blood drawn during | The BEAR Implant (22 mm in<br>diameter and 44mm in length) is<br>cylindrical in shape and<br>comprised of collagen and<br>extracellular matrix derived<br>from bovine connective tissue,<br>which has been cleaned,<br>disinfected and processed by a<br>proprietary manufacturing<br>method. The implant is intended<br>to be used with up to 10 ml of | Same |
| Characteristic | New Device<br>BEAR Implant | Predicate Device*<br>BEAR Implant<br>DEN200035 | Comparison |
| | the surgical implantation<br>procedure. | autologous blood drawn during<br>the surgical implantation<br>procedure. | |
| Operating Principle | The BEAR Implant stabilizes the<br>blood in the gap between the torn<br>ligament ends, facilitating<br>restoration of the ACL. The BEAR<br>Implant is resorbed within 8 weeks<br>and replaced with a fibrovascular<br>repair tissue. | The BEAR Implant stabilizes the<br>blood in the gap between the<br>torn ligament ends, facilitating<br>restoration of the ACL. The<br>BEAR Implant is resorbed within<br>8 weeks and replaced with a<br>fibrovascular repair tissue. | Same |
| Materials | Bovine-derived Type 1 collagen<br>and extracellular matrix | Bovine-derived Type 1 collagen<br>and extracellular matrix | Same - no changes |
| Biocompatibility | No new testing required | Testing completed per ISO<br>10993-1 and FDA guidance | Same - no changes |
| Technical Specifications | No new testing required | As approved in DEN200035 | Same - no changes |
| In Vivo Animal Testing | No new animal testing required | Completed as described in<br>DEN200035 | Changes to Indications did not<br>require new animal testing to<br>validate. |
| Human Clinical Testing | Confirmatory clinical data<br>presented in eSTAR Section:<br>Performance Testing | BEAR II Study (see DEN200035) | De Novo approval based on<br>BEAR II study data; this 510(k)<br>includes confirmatory clinical<br>data from the BEAR III study<br>(G170156) and the BRIDGE<br>Registry (post-market study). |

#### VI. Comparison of Technological Characteristics

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#### VII. Performance or Clinical Testing

No non-clinical or animal performance testing was required to support this 510(k), as the change was limited to the indications for use.

Confirmatory clinical data from the BEAR III Study (IDE #G170156) and the BRIDGE Registry (post-market study) demonstrated that the BEAR Implant subject of this 510(k) is as safe and effective as the predicate device in patients less than 14 years of age and in patients with partial ACL tears.

The BEAR III Study was a prospective multicenter single-arm cohort study of the BEAR Implant that enrolled 151 subjects at 7 U.S. investigational sites. The study eligibility criteria included subjects ≥12 years of age and with partial or complete ACL tears. The two primary outcomes were the IKDC Subjective Knee Evaluation score and IKDC Objective Physical Exam score at post-operative year 2. Safety endpoints included the rate of adverse events (AE), serious adverse events (SAE), UADEs and device-related AEs and SAEs.

The ongoing BRIDGE Registry is a real-world observational registry, with prospective arms, of patients receiving the BEAR Implant at up to 30 U.S. sites. The two primary effectiveness endpoints are

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IKDC Subjective Knee Evaluation score at year 2 and Lachman knee laxity at 1 year. Secondary endpoints include 7 patient-reported outcomes (PRO) and knee-related adverse events.

For purposes of this 510(k) submission, safety and effectiveness data for BEAR Implant patients under age 14 were compared to those ≥14 years from the pooled BEAR III and BRIDGE studies were analyzed; safety and effectiveness data for patients with partial ACL tears were compared to complete ACL tears using the BEAR III dataset alone. Refer to Table 1 for subject accountability by age group and Table 2 for subject accountability by tear type.

| | Baseline | Surgery | 1 Year | 2 Years |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|---------|--------|---------|
| Visit Completed, Subjects<br>≥ 14 Years Old, BEAR III | 167 | 148 | 136 | 89 |
| Visit Completed, Subjects<br><14 Years Old, BEAR III | 3 | 3 | 3 | 2 |
| Visit Completed, Subjects<br><14 Years Old, BRIDGE Registry [1] | 14 | 15 | 7 | 6 |
| [1] Includes the proportion of subjects who have an EDC entry for either IKDC, current<br>status questionnaire, or physical exam at that timepoint EXCLUDING where all assessments<br>were marked as not done. | | | | |

# Table 1: Subject Accountability by Age Group

| Table 2: Subject Accountability by Tear Type | | | |
|----------------------------------------------|--|--|--|
|----------------------------------------------|--|--|--|

| | Baseline | Surgery | 1 Year | 2 Years |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|---------|--------|---------|
| Visit Completed, Subjects with<br>complete tear, BEAR III | 124 | 124 | 114 | 79 |
| Visit Completed, Subjects with<br>partial tear, BEAR III | 27 | 27 | 25 | 12 |
| [1] Includes the proportion of subjects who have an EDC entry for either IKDC, current<br>status questionnaire, or physical exam at that timepoint EXCLUDING where all assessments<br>were marked as not done. | | | | |

Of the 18 subjects under 14 years of age, the mean age was 12.4 ± 1.98 years with a range from 7.7 to 14.0 years, 61.1% were white, 33.3% Black, 5.6% Asian and 11.2% other/refused, and 6.3% were Hispanic/Latino. Of the 27 subjects with a partial tear, 81.5% were white, 7.4% Asian, 3.7% Native Hawaiian or Pacific Islander, and 11.2% other/refused, and 18.5% were Hispanic/Latino.

The analyses supporting this label change were pre-specified in a prospective statistical analysis plan (SAP).

### Safety & Effectiveness by Age

IKDC was compared between subjects <14 years and subjects ≥14 years in a non-inferiority analysis, whereas knee laxity was assessed descriptively, as were AE/SAE data. At 1 and 2 years post-op, subjects <14 years had on average higher IKDC scores than subjects ≥14 years, demonstrating a non-inferior outcome between the

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two age groups. A similar outcome was seen in the Lachman knee laxity test. AEs were analyzed in three age groups, <14 years, 14-18 years and 19+ years. Subjects in the youngest age group (<14 years) experienced rates of AEs, serious adverse events (SAE), and device-related AEs and SAEs that were similar to the oldest subjects (19+ years) and lower than 14-18-year-olds.

# Safety & Effectiveness by Tear Type

There were no differences in effectiveness outcomes (IKDC Subjective, IKDC Physical Exam, Lachman) or safety between subjects with partial ACL tears at baseline and those with complete ACL tears.

In conclusion, the BEAR Implant is as safe and effective in patients under 14 years of age as those over 14 years and as safe and effective in patients with partial ACL tears as those with complete ACL tears. Furthermore, only slight modifications to the BEAR procedure are required to address these patient populations, and no data from this analysis suggest that those surgical modifications are difficult or present new or increased risks to the BEAR procedure. These data support the substantial equivalence of the BEAR Implant subject of this 510(k) with the predicate BEAR Implant.

#### VIII. Special Controls

The BEAR Implant subject of this 510(k) meets the Special Controls established for "Resorbable implant for anterior cruciate ligament (ACL) repair", product classification code QNI, classification regulation 21 CFR 888.3044.

#### IX. Conclusions

Miach Orthopaedics concludes that the BEAR Implant is substantially equivalent to its predicate, the BEAR Implant authorized in DEN200035, and does not raise any new issues or concerns of safety or effectiveness.