PANALOK LOOP ANCHOR

• K Number: K040827
• Device Name: PANALOK LOOP ANCHOR
• Manufacturer: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
• Date Cleared: 2004-04-30 ( 31 days)
• Product Code: MAI , GAM
• Regulation Number: 888.3030
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K002639 , K970896
• Predicate For: K050771

Intended Use

The PANALOK Loop Anchor System 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

The PANALOK Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The absorbable poly lactic acid (PLA) anchor is the identical anchor as that of the BIOKNOTLESS Anchor in design, configuration and dimensions. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.

AI/ML Overview

There is no information in the provided document about acceptance criteria, device performance metrics, or a study report detailing how such criteria were met. The document is a 510(k) summary and an FDA clearance letter for a medical device (Panalok Loop Anchor), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and results from a clinical study or specific validation testing.

The document states that "Biocompatibility studies have demonstrated the Panalok Loop Anchor to be non-toxic, non-irritating, and non-cytotoxic," but it does not provide acceptance criteria for these studies, the reported performance, sample sizes, ground truth establishment, or any details about the study design.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or adjudication methods based on the provided text.

Summary

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K040827 (pg 1.053)

SECTION 2 – 510(k) SUMMARY

APR 3 0 2004	Panalok Loop Anchor
Submitter's Name andAddress:	DePuy Mitcka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062
Contact Person	Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone: [phone]Facsimile: 781-278-9578e-mail: [e-mail]
Name of Medical Device	Classification Name: Screw, Fixation, Bone StapleCommon/Usual Name: Appliance for reconstruction of bone tosoft tissueProprietary Name: Panalok Loop Anchor
Substantial Equivalence	The Panalok Loop Anchor is substantially equivalent to theBioKnotless Anchor (K002639) and has similar indications toPANALOK Anchor System (K970896) manufactured by DePuyMitck, a Johnson & Johnson Company, 249 Vanderbilt Avenue,Norwood, MA 02062.
Device Classification	Bone anchors/screws are classified by FDA as a Class II MedicalDevices under the generic category of Single/Multiple ComponentMetallic Bone Fixation Appliances, Orthopedic Devices Panel(reference 21 CFR §888.3030). Product codes GAM and MAI.
Device Description	The PANALOK Loop Anchor System is a preloaded absorbable
Special 510(k) Premarket Notification: Panalok Loop Anchor	CONFIDENTIAL

DePuy Mitek

:

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K040827 (pg 2 of 3)

disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The absorbable poly lactic acid (PLA) anchor is the identical anchor as that of the BIOKNOTLESS Anchor in design, configuration and dimensions. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.

Indications for Use

The Panalok Loop 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

KNEH

• 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

CONFIDENTIAL

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V.040827 (pg 3 of 3)

4. Capsule shift repair (glenoid rim)

Safety

Biocompatibility studies have demonstrated the Panalok Loop Anchor to be non-toxic, non-irritating, and non-cytotoxic.

---

CONFIDENTIAL

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

Ms. Allyson Barford Regulatory Affairs Associate DePuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Rc: K040827

Trade/Device Name: Panalok Loop Anchor Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM, MAI Dated: March 22, 2004 Received: April 2, 2004

Dear Ms. Barford:

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 markcted predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Mcdical 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 device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

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Page 2 - Ms. Allyson Barford

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. 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

(fg 1 of 2)

510(k) Number (if known): K040827

Device Name: Panalok Loop Anchor

Indications For Use:

The PANALOK Loop Anchor System 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. Biccps 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

Prescription Use X (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)

Mark N. Milkerson

ral, Restorative, Page 1 of 2 and Neurological Devices

K090821

510(k) Number

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fy 2 of

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)

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.