LUPINE LOOP

K050771 · Depuy Mitek, A Johnson & Johnson Company · GAM · Apr 8, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050771
• Device Name: LUPINE LOOP
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lupine 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

Lupine Loop System is a preloaded, absorbable, disposable suture anchor/inserter assembly; used for soft tissue-to-bone fixation in orthopedic procedures. Anchor is constructed of molded Poly (L-lactide) (PLA) polymer; identical in design, configuration, and dimensions to the Panalok Loop Anchor. System may be supplied with Ethibond, Panacryl, or Orthocord sutures. Device is used by surgeons in open or arthroscopic procedures (shoulder, elbow, ankle, knee). The anchor is inserted into bone to secure soft tissue; provides mechanical fixation during the healing process. Benefits include secure tissue reattachment and absorbable material composition, eliminating need for secondary removal.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through bench testing against predetermined acceptance criteria and conformance to USP monographs for suture compatibility.

Technological Characteristics

Absorbable suture anchor system; material: molded Poly (L-lactide) (PLA) polymer. Form factor: preloaded, disposable anchor/inserter assembly. Connectivity: N/A. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for soft tissue to bone fixation in patients requiring postoperative immobilization for shoulder, elbow, ankle, and knee repairs, including Bankart, SLAP, rotator cuff, biceps, ligament, and tendon reconstructions.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Panalok Loop Anchor (K040827)

Reference Devices

• Ethibond Suture (NDA 17-804 and 17-809)
• Orthocord Suture (K040004 and K043298)

Submission Summary (Full Text)

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K050771 1/3

.

APR 8 2005

# 510(k) SUMMARY

Lupine Loop Anchor

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Denise Luciano<br>Senior Regulatory Affairs Specialist<br>DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Telephone: [phone]<br>Facsimile: 781-278-9578<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple<br>Common/Usual Name: Appliance for reconstruction of soft tissue to bone<br>Proprietary Name: Lupine Loop System |
| Substantial Equivalence | Lupine Loop Anchor is substantially equivalent to:<br>Panalok Loop Anchor, K040827, manufactured by DePuy Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical<br>Devices under the generic category of Single/Multiple component<br>metallic bone fixation appliances and accessories.<br><br>Lupine Loop Anchor Systems carry FDA product code MAI, and is<br>classified as Biodegradeable soft tissue fastener under 21 CFR<br>888.3030. |
| Device Description | Lupine Loop System is a preloaded, absorbable disposable suture<br>anchor/ inserter assembly designed to allow soft tissue repair to bone.<br>The absorbable polylactic acid (PLA) anchor is an identical anchor as<br>that of the Panalok Loop Anchor in design, configuration and<br>dimensions. The absorbable anchor is a one piece suture anchor |
| 510(k) Premarket Notification: Special Confidential | |

# Lupine Loop Anchor

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Ko 5077/2/3

constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl may be sold with bor Orthocord Suture (K040004 and K043298).

## Indications for Use

The Lupine Loop Anchor System is indicated for use in soft tissue to The Lupine Doop Antener Systimate 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)

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Safety and Performance

The determination of substantial equivalence for this device was based The determination of subblance. Squareance to consensus and on a delaned device descriptions) ... ... ... Volunary standards: Lore conformed to the USP monograph for the ORTHOCORD suture compatibility and deployment met predetermined acceptance criteria.

Based on the indications for use, technological characteristics, and Dased on the includicate devices, the Lupine Loop System has been Comparison to prociously equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 APR 8

Ms. Denise Luciano Senior Regulatory Affairs Specialist DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K050771

Trade/Device Name: Lupine Loop System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances Regulatory Class: II Product Code: GAM, MAI Dated: March 24, 2005 Received: March 25, 2005

Dear Ms. Luciano:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications
referenced above and have determined the devices morketed in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Medical Device Amendments for use stated in the enclosure) to regary manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment data areasiene of the Federal Food. Drug commerce prior to May 28, 1970, the enactions of the Federal Food, Drug, devices that have been recults in accondance who approval application (PMA).
and Cosmetic Act (Act) that do not require approval as a provisions of the Act . The and Cosmetic Act (Act) that do not require approvate on trols provisions of the Act. The Act. The You may, therefore, market the device, sugles to the gents for annual registration, listing of
general controls provisions of the Act include required withings areas; misbran general controls provisions of the Act merade requirement of the magainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See above) into entire major regulations affecting your device
it may be subject to such additional controls. Exist. Rets 808 In addition FD it may be subject to such additional controls: Existing and to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to and can be found in the Code of Federal Regulations, The device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualite of a substition with other requirements of the Act
that FDA has made a determination that your device of the Frequirements of the Act that FDA has made a determination macyou derres over Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations and including, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not assetse req comply with all the Act s requirements, menualism increasing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electroni CFR Part 807); labeling (21 CFR Part 801); good and 1200; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Denise Luciano

This letter will allow you to begin marketing your device as described in your Section 510(k)
The Sun Support of Caliner of a line of select station as typer device to a lega This letter will allow you to begin marketing your actives of your device of your device to a legally
premarket notification. The FDA finding of substantial equipe of this premarket notification. The IDA Intuing of backanda organital organits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the results of the may on 10, 276, 0120 - Alge masses note the requiried If you desire specific advice for your device on our acomig incase mote ( - )
contact the Office of Compliance at [phone] . contact the Office of Compliance at (240) 270 - 1240 - 124 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Pro Division of Small "Misbranding by reference to premarks noutleansm (er es ext from the Division of Small)
other general information on your responsibilities under the Act from the Division of other general information on your responsion its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (index html Manufacturers, International and Consulter Assistance at too be Industry/support/index.html.

Sincerely yours,

Rar le Th

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K05077/1/2

# INDICATIONS FOR USE

510(k) Number (if known):

Device Names: Lupine Loop System

Indications for Use:

The Lupine 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
- 3. Rolator cull repan
4a. Capsule shift/capsulo-labral reconstruction, at the anterior crime of the be
- 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. Loint 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.

510(k) Premarket Notification: Special Lupine Loop Anchor

Confidential

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ARTHROSCOPIC PROCEDÚRES SHOULDER

1. Bankart repair

2. SLAP lesion repair

3. Rotator cuff repair

- 4. Capsule shift repair (glenoid rim)
Prescription Use 7 (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)

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K050771

510(k) Premarket Notification: Special Lupine Loop Anchor

Confidential