BIO-ANCHOR

K964805 · Linvatec Corp. · MAI · Jun 9, 1997 · Orthopedic

Device Facts

• Record ID: K964805
• Device Name: BIO-ANCHOR
• Applicant: Linvatec Corp.
• 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 Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction. The Bio-Anchor Absorbable Suture Anchor is available in a 3.5mm size.

Device Story

Bio-Anchor is a cylindrical, bioabsorbable PLLA suture anchor featuring three circular ribs and a central eyelet. Designed for orthopedic soft tissue-to-bone fixation; surgeon threads non-absorbable polyester suture through the eyelet post-implantation. Lack of permanent suture attachment enables sliding knot techniques. Used by orthopedic surgeons in clinical settings. Device provides mechanical fixation for tendons and ligaments to bone; facilitates healing by securing tissue during repair. Benefits include bioabsorbability, reducing need for secondary removal procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Poly (L-lactic) acid (PLLA). Form factor: 3.5mm diameter cylindrical anchor with three circular ribs. Energy source: None (mechanical). Sterilization: ETO. Connectivity: None. Software: None.

Indications for Use

Indicated for soft tissue to bone fixation in orthopedic applications (shoulder, foot/ankle, elbow/wrist/hand, knee), excluding anterior or posterior cruciate ligament repair/reconstruction. Specific procedures include Bankart, SLAP, rotator cuff, capsular shift, biceps tenodesis, deltoid, hallux valgus, instability, Achilles, midfoot, ligament reconstructions, tennis elbow, and patellar realignment.

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

• Linvatec Preloaded Soft Tissue Anchor (K953954)
• Linvatec Bio-Anchor Absorbable Suture Anchor (K955486)

Submission Summary (Full Text)

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K964805

11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax [phone]

Carol A. Weideman, Ph.D.

Manager, Regulatory and Clinical Affairs

JUN - 9 1997

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Bio-Anchor™ Absorbable Suture Anchor, 510(k) Number K964805.

## A. Submitter

Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 33773

## B. Company Contact

Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Affairs

## C. Device Name

Trade Name: Bio-Anchor
Common Name: Suture Anchor
Classification Name: Soft tissue to bone fixation device

## D. Predicate/Legally Marketed Devices

Linvatec Preloaded Soft Tissue Anchor
Linvatec Bio-Anchor

A Bristol-Myers Squibb Company

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Summary of Safety and Effectiveness
Bio-Anchor Absorbable Suture Anchor
510(k) # K964806
Page 2

## E. Device Description

The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.

The material used for this device is:

Anchor - Poly (L-lactic) acid (PLLA)

## F. Intended Use

The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

The Bio-Anchor Absorbable Suture Anchor is available in a 3.5mm size.

## G. Substantial Equivalence

The Bio-Anchor Absorbable Suture Anchor is substantially equivalent in function and intended use to Linvatec’s Preloaded Soft Tissue Anchor and Linvatec’s Bio-Anchor. The material is identical to the original Linvatec Bio-Anchor.

The similarities/dissimilarities to the predicates are shown in the attached table.

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Summary of Safety and Effectiveness
Bio-Anchor Absorbable Suture Anchor
510(k) # K964805
Page 3

# SUBSTANTIAL EQUIVALENCE INFORMATION:

## CHART OF SIMILARITIES AND DISSIMILARITIES

| Company Name | Device Name | Intended Use | Material | Single-Use/Reusable | Sizes |
| --- | --- | --- | --- | --- | --- |
| New Product:
Linvatec | Bio-Anchor | Soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction. | Poly (L-lactic) acid | Single-Use
ETO Sterilization | 3.5mm diameter
Suture: USP Sizes #0 to #2 |
| Predicate:
Linvatec: Preloaded Soft Tissue Anchor
510(k) # K953954 | Preloaded Soft Tissue Anchor | Soft tissue to bone fixation | Titanium Alloy
Suture: Non-absorbable Braided Polyester | Single-Use
Gamma Sterilization | 2.5mm - 5.2mm diameter
Suture: USP sizes #0 to #2 |
| Predicate:
Linvatec: Bio-Anchor Absorbable Suture Anchor
510(k) #K955486 | Bio-Anchor | Soft tissue to bone fixation | Poly (L-lactic) acid
#0, #1, or #2 Non-Absorbable Suture | Single-Use
ETO Sterilization | 3.5mm diameter
Suture: USP Sizes #0 to #2 |

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

JUN - 9 1997

Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Affairs
Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 34643

Re: K964805
Bio-Anchor® Absorbable Suture Anchor Regulatory Class: II
Product Code: MAI
Dated: March 20, 1997
Received: March 21, 1997

Dear Dr. Weideman:

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 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.

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Page 2 - Carol A. Weideman, Ph.D.

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

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Einvatec

BBI Concept Boulevard Largo, Florida 33773-4908 813 392-6464

June 3, 1997

Page 1 of 2

510(k) Number (if known): K964805

Device Name: BIO-ANCHOR™ ABSORBABLE SUTURE ANCHOR

Indications for Use:

The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

## Shoulder

1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs

## Foot and Ankle

1. Hallux Valgus repairs
2. Medial or lateral instability repairs/reconstructions
3. Achilles tendon repairs/reconstructions
4. Midfoot reconstructions

## Elbow, Wrist and Hand

1. Scapholunate ligament reconstructions
2. Ulnar or radial collateral ligament reconstructions
3. Tennis elbow repair
4. Biceps tendon reattachment

Prescription Use ☑
(Per 21 CFR 801.109)


A Bristol-Myers Squibb Company

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K964805 Bio-Anchor™ Absorbable Suture Anchor
Indications for Use
June 3, 1997
Page 2 of 2

## Knee

1. Extra-capsular repairs and reattachments of:
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament or joint capsule to tibia
d. joint capsule closure to anterior proximal tibia
2. Extracapsular reconstruction, iliotibial band tenodesis
3. Patellar realignment and tendon repairs

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

(Optional Format 1-2-96)