K Number
K040827
Device Name
PANALOK LOOP ANCHOR
Date Cleared
2004-04-30

(31 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
More Information

Not Found

No
The device description and intended use focus on a mechanical suture anchor system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

No.
The device is an implantable suture anchor system used for soft tissue to bone fixation after injury or disease, which is a restorative rather than therapeutic function.

No
The device, the PANALOK Loop Anchor System, is described as a surgical implant for soft tissue to bone fixation. Its intended uses involve various repairs and reconstructions, which are therapeutic interventions rather than diagnostic procedures. There is no mention of the device being used to identify or analyze diseases or conditions.

No

The device description clearly states it is a "preloaded absorbable disposable suture anchor/inserter assembly," which are physical hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical device used for soft tissue to bone fixation in various anatomical locations (shoulder, elbow, ankle, foot, knee). This is a therapeutic and structural function, not a diagnostic one.
  • Device Description: The description details a suture anchor/inserter assembly made of absorbable material. This is a physical implant used during surgery.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
  • Performance Studies: The mentioned performance studies focus on biocompatibility, which is relevant for implanted devices, not IVDs.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PANALOK Loop Anchor System does not fit this description.

N/A

Intended Use / 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 4. Capsule shift repair (glenoid rim)

Product codes (comma separated list FDA assigned to the subject device)

GAM, MAI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Elbow, Ankle, Foot, Knee

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002639, K970896

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

K040827 (pg 1.053)

SECTION 2 – 510(k) SUMMARY

APR 3 0 2004Panalok Loop Anchor
Submitter's Name and
Address:DePuy Mitck
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062
Contact PersonAllyson 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 DeviceClassification Name: Screw, Fixation, Bone Staple
Common/Usual Name: Appliance for reconstruction of bone to
soft tissue
Proprietary Name: Panalok Loop Anchor
Substantial EquivalenceThe 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 ClassificationBone 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 DescriptionThe PANALOK Loop Anchor System is a preloaded absorbable
Special 510(k) Premarket Notification: Panalok Loop AnchorCONFIDENTIAL

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
    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

KNEH

    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

CONFIDENTIAL

2

V.040827 (pg 3 of 3)

  1. 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
    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. Biccps 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

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)