MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM

K970896 · ETHICON, Inc. · MAI · Jun 9, 1997 · Orthopedic

Device Facts

• Record ID: K970896
• Device Name: MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Jun 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Mitek 3.5mm Absorbable Suture Anchor System is intended for use in soft tissue to bone fixation in association with adequate post-operative immobilization.

Device Story

The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is a sterile, single-use implant designed for soft tissue-to-bone fixation. The system consists of a poly(L-lactide) (PLL) anchor pre-threaded with ETHICON absorbable poly(L-lactide/glycolide) surgical suture and two needles, supplied with a disposable inserter. The device is used by surgeons in open or arthroscopic procedures. The surgeon drills a 3.5mm diameter by 18mm deep hole in the bone using Mitek-specific instruments, then implants the anchor to secure soft tissue. The device provides mechanical fixation to facilitate healing, after which the anchor and suture are intended to be absorbed by the body. It is intended for use in various orthopedic repairs including shoulder, elbow, ankle, and knee procedures.

Clinical Evidence

Bench testing only. Nonclinical laboratory testing was performed to assess in vitro and in vivo strength and failure modes.

Technological Characteristics

Anchor material: Poly(L-lactide) (PLL) homopolymer. Suture material: Absorbable poly(L-lactide/glycolide). Dimensions: 3.5mm diameter anchor, 18mm deep drill hole. Supplied sterile with disposable inserter. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue to bone fixation in open and arthroscopic procedures of the shoulder (Bankart, SLAP, rotator cuff, capsule shift, biceps tenodesis, AC separation), elbow (biceps tendon reattachment), ankle (Achilles repair, lateral/medial stabilization), and knee (MCL/LCL repair, joint capsule closure, posterior oblique ligament repair, ITB tenodesis, patellar ligament/tendon avulsion). Requires post-operative 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

• Mitek 3.5mm Absorbable Suture Anchor System (K970896)

Submission Summary (Full Text)

{0}

JUN - 9 1997

# SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS K970896

### 510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

**NEW DEVICE NAME:** Modified Mitek 3.5mm Absorbable Suture Anchor System

**PREDICATE DEVICE NAME:** Mitek 3.5mm Absorbable Suture Anchor System

### 510(k) SUMMARY

### Device Description

The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is designed to implant within a pre-drilled bone hole site and provide a means for firmly securing soft tissue to bone using sutures.

The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System includes a PLL (homopolymer poly (L(-)-lactide) anchor pre-threaded with ETHICON Absorbable poly (L-lactide/glycolide) Surgical Suture, Undyed, two pre-attached surgical needles, and a pre-assembled disposable inserter. The system is supplied sterile and ready for use. Mitek instruments, drill and drill guide, are to be used to install the Mitek PANALOK 3.5mm Absorbable Suture Anchor. The drill bit creates a hole 3.5mm in diameter by 18mm deep.

Poly (L(-)-lactide) polymer is nonpyrogenic.

Modified PANALOK Wedge Absorbable Suture Anchor System ETHICON, Inc.

{1}

SUMMARY OF SAFETY AND EFFECTIVENESS, Continued)

## Intended Use

The Modified Mitek 3.5mm Absorbable Suture Anchor System is intended for use in soft tissue to bone fixation in association with adequate post-operative immobilization.

## Indications Statement

The Mitek PANALOK 3.5mm Absorbable Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows:

## OPEN PROCEDURES

### SHOULDER:

1. Bankart repair
2. SLAP lesion repair
3. Rotator cuff repair
4. a. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
5. Biceps tenodesis
6. Acromio-clavicular separation

### ELBOW:

1. Biceps tendon/reattachment

### ANKLE:

1. Achilles tendon repair/reconstruction
2. Lateral stabilization
3. Medial stabilization at the medial talus site

### KNEE:

1. Medial collateral ligament repair
2. Lateral collateral ligament repair
3. Join 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

Continued on next page

Modified PANALOK Wedge Absorbable Suture Anchor System
ETHICON, Inc.

{2}

SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

## Indication Statement (continued)

### ARTHROSCOPIC PROCEDURES

#### SHOULDER:

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

#### Technological Characteristics

The modified device has the same technological characteristics as the predicate device. There are no changes in chemistry, material or composition. When compared to the predicate device, it only differs in that the ETHICON Absorbable poly (L-lactide/glycolide) Surgical Suture, Undyed is being attached to its anchor system.

#### Performance Data

Nonclinical laboratory testing was performed to assess the *in vitro* and *in vivo* strength and failure modes.

#### Conclusions

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

#### Contact

Gregory Jones
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151

#### Date

March 10, 1997

Modified PANALOK Wedge Absorbable Suture Anchor System
ETHICON, Inc.

{3}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 9 1997

Mr. Gregory Jones
Director, Regulatory Affairs
Ethicon, Inc.
P.O. Box 151
Somerville, New Jersey 08876-0151

Re: K970896
Trade Name: Mitek 3.5mm Panalok Wedge
Absorbable Suture Anchor System
Regulatory Class: II
Product Code: MAI
Dated: March 10, 1997
Received: March 11, 1997

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic

{4}

Page 2 - Mr. Gregory Jones

GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{5}

INDICATION FOR USE

510(k) Number (if known): K970896

Device Name: Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System

Indications for Use: The Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post operative immobilization as follows:

| Open Procedures | Arthroscopic Procedures |
| --- | --- |
| Shoulder:
1. Bankart repair
2. Slap lesion repair
3. Rotator cuff repair
4. a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
5. Biceps tenodesis
6. Acromio-clavicular separation | Shoulder:
1. Bankart repair
2. Slap lesion repair
3. Rotator cuff repair
4. Capsule shift repair (glenoid rim) |

Elbow:
1. Bicep tendon reattachment

Ankle:
1. Achilles tendon repair/reconstruction
2. Lateral stabilization
3. Medial stabilization at the talus site

Knee:
1) Medial collateral ligament repair
2) Lateral collateral ligament repair
3) Joint capsule closure to the 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

Modified PANALOK Wedge Absorbable Suture Anchor System
ETHICON, Inc.

{6}

K970896

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ OR Over-The Counter Use ☐
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970896

(Optional Format 1-2-9G)

Modified PANALOK Wedge Absorbable Suture Anchor System ETHICON, Inc. iv