The Bioknotless BR Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site; 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus; 5. Biceps tenodesis 6. Acromio-clavicular separation; 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment; 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction; 2. Lateral stabilization 3. Medial stabilization at the medial talus site; Foot: Hallux Valgus reconstruction; 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair; 2. Lateral collateral ligament repair; 3. Joint capsule closure to anterior proximal tibia; 4. Posterior oblique ligament or joint capsule to tibia repair; 5. Extra capsular reconstruction / ITB tenodesis; 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER; 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4. Capsule shift repair (glenoid rim) The Lupine Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair, 2. SLAP lesion repair 3. Rotator cuff repair, 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site, 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, 5. Biceps tenodesis, 6. Acromio-clavicular separation, 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment, 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction, 2. Lateral stabilization 3. Medial stabilization at the medial talus site, Foot: Hallux Valgus reconstruction, 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair, 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia., 4. Posterior oblique ligament or joint capsule to tibia repair, 5. Extra capsular reconstruction / ITB tenodesis, 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER:1. Bankart repair, 2. SLAP lesion repair, 3. Rotator cuff repair, 4. Capsule shift repair (glenoid rim)

Device Description

Bioknotless BR Anchor / Lupine BR are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus. The anchor material is changing from absorbable polylactic acid (PLA) in the predicate device to Biocryl Rapide a B-TCP/PLGA biocomposite material in the proposed devise. The anchor is a one piece suture anchor sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

AI/ML Overview

The Bioknotless BR Anchor / Lupine BR Anchor is a medical device for soft tissue repair to bone. The acceptance criteria and supporting study details are as follows:

1. Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Mechanical Performance	The device should demonstrate equivalent or superior mechanical properties compared to the predicate device, specifically regarding its ability to withstand forces during soft tissue to bone fixation. This would typically involve metrics such as pull-out strength, insertion torque, and degradation characteristics consistent with its intended use and duration of support.	The submission states: "Bench testing was performed demonstrating that the Bioknotless BR Anchor / Lupine BR Anchor met predetermined acceptance criteria." While specific numerical performance values are not provided in this summary, the FDA's clearance (K070925) indicates that the device's mechanical performance, derived from bench testing, was found to be acceptable and substantially equivalent to the predicate device. The change in material from absorbable polylactic acid (PLA) to Biocryl Rapide (a ß-TCP/PLGA biocomposite) implies that the new material's mechanical and degradation properties were thoroughly evaluated to ensure continued safety and effectiveness for soft tissue to bone fixation. The use of Biocryl Rapid in existing Mitek Milagro Screws (K032717, K060830) for similar indications further supports its proven mechanical suitability.
Biocompatibility	The device material must be biocompatible and elicit no unwarranted inflammatory or toxic response in vivo.	While not explicitly detailed as a separate "study" section, the fact that the material (Biocryl Rapid, a ß-TCP/PLGA biocomposite) is "currently used in the Mitek Milagro Screw (K032717, K060830)" implies that its biocompatibility has already been established and accepted by the FDA for similar applications in bone fixation. New biocompatibility testing specific to this device would likely have been conducted and reviewed as part of the overall bench testing, satisfying relevant ISO standards (e.g., ISO 10993 series).
Dimensional Equivalence	The dimensions of the anchor should be identical to the predicate device to ensure similar surgical handling and implantation.	The submission explicitly states: "The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus." This indicates that this criterion was met by design.

2. Sample Size Used for the Test Set and Data Provenance

The summary states that "Bench testing was performed". This implies that the test set consisted of a number of physical anchor samples that underwent mechanical and potentially other laboratory tests. However, the specific sample size (e.g., number of anchors tested for pull-out strength, number of samples for degradation studies) is not specified in the provided 510(k) summary.

Regarding data provenance, the testing was performed as bench testing, meaning it was conducted in a laboratory setting. This is a form of prospective data collection specifically designed to evaluate the physical and mechanical properties of the device before clinical use. The country of origin of the data is not explicitly stated but would typically be the location of the manufacturing and R&D facilities of DePuy Mitek (USA, as inferred from the submitter's address).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of medical device (suture anchor) does not typically involve "experts" establishing a "ground truth" for a "test set" in the way an AI diagnostic algorithm would. For a mechanical device, the "ground truth" is established by objective engineering specifications, material science standards, and established biomechanical testing protocols.

The "experts" involved would be:

Engineers and material scientists employed by DePuy Mitek who designed the product and established the design specifications and testing protocols.
Laboratory technicians who conducted the bench tests according to established procedures.
Regulatory specialists who ensure the testing meets regulatory requirements and standards.

Their qualifications would be relevant engineering, material science, or biological science degrees and experience in medical device development and testing.

4. Adjudication Method for the Test Set

As this is bench testing of a physical device, an "adjudication method" in the context of human interpretation (like 2+1 or 3+1 for imaging studies) is not applicable. The "adjudication" for bench test results involves:

Comparison to predetermined acceptance criteria: Test results are directly compared against established numerical thresholds (e.g., minimum pull-out strength).
Verification of methodology: Ensuring that the testing was performed according to validated protocols and standards.
Statistical analysis: Results are typically analyzed statistically to confirm reliability and meet acceptance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device. This type of study is typically used for diagnostic devices or AI algorithms where human interpretation of data (e.g., medical images) is involved, and the goal is to assess the impact of the device on human reader performance. The Bioknotless BR Anchor / Lupine BR Anchor is a surgical implant, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an "algorithm only without human-in-the-loop performance" is not applicable. This phrasing refers to the performance of artificial intelligence or computational algorithms. The Bioknotless BR Anchor / Lupine BR Anchor is a physical medical implant, not an algorithm. Its performance is assessed through bench testing (mechanical, material, and biocompatibility studies) and potentially clinical outcomes for previously approved similar products.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective engineering and material science metrics derived from:

Established mechanical properties defined by industry standards and internal design specifications (e.g., minimum tensile strength, maximum degradation rate).
Biocompatibility standards (e.g., ISO 10993 series) for the material.
Dimensional specifications for the physical anchor.

In short, the ground truth is based on physical and chemical measurements against predefined, objective standards.

8. Sample Size for the Training Set

There is no explicit "training set" mentioned or implied for this device in the context of machine learning or AI. The term "training set" is relevant for AI algorithms that learn from data.

If interpreted loosely as the historical data and experience informing the device's design, then:

The predicate device (Bioknotless Plus Anchor / Lupine Anchor Plus) serves as a "trained" entity from which the new device derives its substantial equivalence. The design and performance data from this predicate, and other similar devices, implicitly "trained" the design choices for the Bioknotless BR Anchor / Lupine BR Anchor.
The material Biocryl Rapid has prior use in "Mitek Milagro Screw (K032717, K060830)," which means clinical and bench data from those devices provided a "training set" for the material's properties and safety profile.

9. How the Ground Truth for the Training Set Was Established

Given the interpretation above:

For the predicate device, its ground truth would have been established through its own bench testing, potentially animal or clinical studies, and successful marketing and clinical use, all demonstrating its safety and effectiveness.
For the Biocryl Rapid material, the ground truth would have been established through extensive material science testing (mechanical, chemical, degradation), biocompatibility studies (in vitro and in vivo), and documented clinical use in other FDA-cleared devices like the Mitek Milagro Screw.

In essence, the "ground truth" for the "training set" (prior devices and materials) was established through comprehensive scientific and regulatory evaluation over time.

Summary

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K070925

510(k) SUMMARY

MAY - 2 2007

Bioknotless BR Anchor / Lupine BR Anchor

Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Kristine ChristoSenior Regulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-828-3359Facsimile: 508-977-6955e-mail: KChristo@Dpyus.jnj.com
Name of Medical Device	Classification Name:	Screw, Fixation, Bone Staple
	Common/Usual Name:	Appliance for reconstruction of softtissue to bone
	Proprietary Name:	Bioknotless Anchor / Lupine Anchor
Substantial Equivalence	Bioknotless BR Anchor is substantially equivalent to:Bioknotless Plus Anchor, K062170, manufactured by DePuy Mitek.RapideLupine Anchor is substantially equivalent to:Lupine Plus Anchor, K062170, manufactured by DePuy Mitek
Device Classification	Bone anchors/screws are classified by the FDA as Class II MedicalDevices under the generic category of Single/Multiple componentmetallic bone fixation appliances and accessories.Bioknotless Anchor / Lupine Anchor Systems carry FDA product codeMAI and is classified as single / multiple component metallic bonefixation appliances and accessories soft tissue fastener under 21 CFR 888.3030.
Device Description	Bioknotless BR Anchor / Lupine BR are a preloaded, disposable

510(k) Premarket Notification: Special Bioknotless BR Anchor / Lupine BR Anchor Confidential

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suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus. The anchor material is changing from absorbable polylactic acid (PLA) in the predicate device to Biocryl Rapide a B-TCP/PLGA biocomposite material in the proposed devise. The anchor is a one piece suture anchor sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

Biocryl Rapid, a ß-TCP/PLGA biocomposite material is currently used in the Mitek Milagro Screw (K032717, K060830) which is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Additionally, the 7, 8 and 9 mm x23 mm Mitek Milagro screws are indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Indications for Use

The Bioknotless Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site; 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus; 5. Biceps tenodesis 6. Acromio-clavicular separation; 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment; 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction; 2. Lateral stabilization 3. Medial stabilization at the medial talus site; Foot: Hallux Valgus reconstruction; 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair; 2. Lateral collateral ligament repair; 3. Joint capsule closure to anterior proximal tibia; 4. Posterior oblique ligament or joint capsule to tibia repair; 5. Extra capsular reconstruction / ITB tenodesis; 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER; 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4. Capsule shift repair (glenoid rim) The Lupine Anchor is indicated for use in soft tissue to bone

fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER: 1. Bankart repair, 2. SLAP lesion repair 3. Rotator cuff repair, 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site, 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, 5. Biceps tenodesis, 6. Acromio-clavicular separation, 7. Deltoid repair

ELBOW: 1. Biceps tendon reattachment, 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction, 2. Lateral stabilization 3. Medial stabilization at the medial talus site, Foot: Hallux Valgus reconstruction, 4. Midfoot reconstruction

KNEE: 1. Medial collateral ligament repair, 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia., 4. Posterior oblique ligament or joint capsule to tibia repair, 5. Extra capsular reconstruction / ITB

Confidential

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tenodesis, 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER:1. Bankart repair, 2. SLAP lesion repair, 3. Rotator cuff repair, 4. Capsule shift repair (glenoid rim)

Safety and Performance

The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the Bioknotless BR Anchor / Lupine BR Anchor met predetermined acceptance criteria.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Bioknotless BR Anchor and Rapide Lupjne Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek, a Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K070925 Trade/Device Names: Bioknotless BR Anchor Lupine BR Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, GAM, GAS, GAT Dated: April 2, 2007 Received: April 3, 2007

MAY - 2 2007

Dear Ms. Christo:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, subject to the general controls provisions of the Act. 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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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

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Page 2 - Ms. Kristine Christo

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Douglare Buellm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K070925

Device Names: Bioknotless BR Anchor

Indications for Use: The Bioknotless BR Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

Bankart repair
SLAP lesion repair
Rotator cuff repair

4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site

4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus

Biceps tenodesis
Acromio-clavicular separation
Deltoid repair

ELBOW

Biceps tendon reattachment
Tennis elbow repair

ANKLE

Achilles tendon repair/reconstruction
Lateral stabilization
Medial stabilization at the medial talus site

Foot: Hallux Valgus reconstruction

Midfoot reconstruction

KNEE

1. Medial collateral ligament repair

Lateral collateral ligament repair
Joint capsule closure to anterior proximal tibia
Posterior oblique ligament or joint capsule to tibia repair
Extra capsular reconstruction / ITB tenodesis
Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES SHOULDER

1. Bankart repair

SLAP lesion repair
Rotator cuff repair
Capsule shift repair (glenoid rim)

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(19)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Page 1 of
	(Division Sign-Off)
510(k) Premarket Notification: Special Bioknotless BR Anchor / Lupine BR Anchor	Division of General, Restorative, Confidential and Neurological Devices

510(k) Number_KO 70925

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INDICATIONS FOR USE

510(k) Number (if known): K070925

Device Names: Lupine BR Anchor

INDICATIONS FOR USE: The Lupine BR Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

1. Bankart repair
1. SLAP lesion repair
1. Rotator cuff repair
4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
1. Biceps tenodesis
1. Acromio-clavicular separation
1. Deltoid repair

ELBOW

1. Biceps tendon reattachment
1. Tennis elbow repair

ANKLE

1. Achilles tendon repair/reconstruction
1. Lateral stabilization
1. Medial stabilization at the medial talus site
Foot: Hallux Valgus reconstruction
1. Midfoot reconstruction

KNEE

1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Joint capsule closure to anterior proximal tibia
1. Posterior oblique ligament or joint capsule to tibia repair
1. Extra capsular reconstruction / ITB tenodesis
1. Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES

SHOULDER

1. Bankart repair
1. SLAP lesion repair
1. Rotator cuff repair
1. Capsule shift repair (glenoid rim)

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

510(k) Premarket Notification: Special Bioknotless BR Anchor / Lupine BR Anchor Confidential

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.