Who is the manufacturer of PANALOK LOOP ANCHOR?

Depuy Mitek, A Johnson & Johnson Company filed the 510(k) submission for PANALOK LOOP ANCHOR (K040827).

What is the FDA product code for PANALOK LOOP ANCHOR?

MAI. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PANALOK LOOP ANCHOR?

510(k) clearance (submission type: Special).

What are the predicate devices for PANALOK LOOP ANCHOR?

BioKnotless Anchor (K002639); PANALOK Anchor System (K970896).

Who can help prepare an FDA 510(k) submission like PANALOK LOOP ANCHOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PANALOK LOOP ANCHOR

K040827 · Depuy Mitek, A Johnson & Johnson Company · MAI · Apr 30, 2004 · Orthopedic

Device Facts

Record ID	K040827
Device Name	PANALOK LOOP ANCHOR
Applicant	Depuy Mitek, A Johnson & Johnson Company
Product Code	MAI · Orthopedic
Decision Date	Apr 30, 2004
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

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 Story

Preloaded absorbable suture anchor/inserter assembly; used for soft tissue-to-bone fixation in orthopedic procedures. Anchor constructed of molded Poly(L-lactide) (PLA) polymer. Device is disposable; used by surgeons in open or arthroscopic procedures. Provides mechanical fixation of soft tissue to bone to facilitate healing. Biocompatibility confirmed via non-toxic, non-irritating, non-cytotoxic testing.

Clinical Evidence

No clinical data. Biocompatibility studies demonstrated the device to be non-toxic, non-irritating, and non-cytotoxic.

Technological Characteristics

Absorbable suture anchor; material: molded Poly(L-lactide) (PLA) polymer. Preloaded disposable inserter assembly. Class II device (21 CFR 888.3030).

Indications for Use

Indicated for soft tissue to bone fixation in patients requiring surgical repair of shoulder, elbow, ankle, and knee ligaments/tendons, including Bankart, SLAP, rotator cuff, biceps, Achilles, and collateral ligament repairs. Requires postoperative immobilization.

Regulatory Classification

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.

Predicate Devices

BioKnotless Anchor (K002639)
PANALOK Anchor System (K970896)

Related Devices

K062170 — BIOKNOTLESS AND LUPINE PLUS ANCHORS · Depuy Mitek, A Johnson & Johnson Company · Aug 22, 2006
K002639 — BIOKNOTLESS ANCHOR · Mitek Products · May 11, 2001
K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES · Conmed Linvatec · Oct 19, 2009
K023192 — STRYKER BIOZIP SUTURE ANCHOR · Stryker Endoscopy · Mar 20, 2003
K012465 — MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR · Bonutti Research, Inc. · Oct 29, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ # K040827 (pg 1.053) ## SECTION 2 – 510(k) SUMMARY | APR 3 0 2004 | Panalok Loop Anchor | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Name and Address: | DePuy Mitck a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 | | Contact Person | Allyson Barford Regulatory Affairs Associate DePuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 Telephone: 781-251-2794 Facsimile: 781-278-9578 e-mail: abarford@dpyus.jnj.com | | Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple Common/Usual Name: Appliance for reconstruction of bone to soft tissue Proprietary Name: Panalok Loop Anchor | | Substantial Equivalence | The Panalok Loop Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and has similar indications to PANALOK Anchor System (K970896) manufactured by DePuy Mitck, a Johnson & Johnson Company, 249 Vanderbilt Avenue, Norwood, MA 02062. | | Device Classification | Bone anchors/screws are classified by FDA as a Class II Medical Devices under the generic category of Single/Multiple Component Metallic 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 : {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 (301) 594-4659. 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 (301) 443-6597 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 {5}------------------------------------------------ ### 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** {6}------------------------------------------------ # 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)