BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR

K983186 · Linvatec Corp. · MAI · Oct 21, 1998 · Orthopedic

Device Facts

• Record ID: K983186
• Device Name: BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
• Applicant: Linvatec Corp.
• Product Code: MAI · Orthopedic
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications : 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. Altoid 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 Knee 1. Extracapsular 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 Bladder Neck Suspension 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Story

Pre-loaded Bio-Anchor is an injection-molded poly(L-lactic) acid suture anchor with attached nonabsorbable braided polyester suture (USP size #2). Device features circular ribs with three cylindrical holes perpendicular to long axis. Suture passes through anchor eyelet and attaches to wire via shrink tubing. Used in arthroscopic or open surgical procedures by surgeons to reattach soft tissue to bone. Device provides mechanical fixation for various orthopedic and urological repairs. Single-use, sterile, ETO-sterilized.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Anchor material: Poly(L-lactic) acid. Suture: Non-absorbable braided polyester (USP #2). Suture sleeve: FEP Teflon. Shrink tube: MIL-1023053/11B or polyester. Wire: 316 stainless steel. Dimensions: 3.5mm x 10.5mm. Single-use. ETO sterilization.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, knee, foot, ankle, elbow, wrist, hand, and bladder neck suspension procedures (including female urinary incontinence due to urethral hypermobility).

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

• Bio-Anchor (K964805, K963369)
• Revo/Mini Revo Preloaded Suture Anchors (K953954)

Submission Summary (Full Text)

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# OCT 21 1998

October 15,1998

### 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 the 510(k) Summary of Safety and submitting hereby Effectiveness for the Pre-loaded Bio-Anchor Absorbable Suture Anchor, 510(k) Number K983186.

#### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

K983186

#### Company Contact B.

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs

:

#### c. Device Name

Trade Name:

| | | Bioabsorbable Suture Anchor |
|-----------------------|---|-----------------------------------------|
| Common Name | : | Suture Anchor |
| Classification Names | : | None Assigned |
| Proposed Class/Device | : | Class II, 87 MAI, Fastener |
| Product Code | : | Fixation, Biodegradable,<br>Soft Tissue |

Bio-Anchor, Pre-loaded

#### Predicate/Legally Marketed Devices D.

Bio-Anchor Linvatec Corporation

Pre-loaded Soft Tissue Anchors Revo/Mini Revo Linvatec Corporation

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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510 (k) # K983186 October 15, 1998 Page 2 of 4

### E. Device Description

The Pre-loaded Bio-Anchor is an injection molded Poly (Llactic) acid suture anchoring device with an attached nonabsorbable braided polyester surure USP size #2. The device circular ribs in shape with three cylindrical i s perpendicular to the long axis. The suture is passed through the eyelet of the anchor and attached to a wire by shrink tubing.

#### F. Intended Use

The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications :

#### 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. Altoid 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

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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510 (k) # K983186 October 15, 1998 Page 3 of 4

### F. Intended Use (con't)

#### Knee

- l. Extracapsular 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

#### Bladder Neck Suspension

- 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.
#### Substantial Equivalence ઉં.

The Pre-loaded Bio-Anchor is substantially equivalent in design, function and intended use to the Bio-Anchor (Linvatec Corporation), and the Revo/Mini Revo Preloaded Suture Anchors, (Linvatec Corporation) .

Testing has been done to prove safety and effectiveness of the devices.

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

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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510(k) # K983186 October 15, 1998 Page 4of 4

## CHART OF SIMILARITIES AND DISSIMILARITIES

| CHART OF SIMILARITIES AND DISSIMILARITIES | | | | | |
|----------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------|
| Company | Device Name | Intended Use | Material | Single-Use<br>Reusable | Sizes |
| NEW PRODUCT<br>Linvatec | Pre-loaded Bio-<br>Anchor<br>Absorbable<br>Suture Anchor | Soft tissue to bone<br>fixation for shoulder,<br>knee, foot, ankle,<br>elbow, wrist, hand, and<br>bladder neck suspension<br>procedures. | Anchor: Poly (L-lactic)acid<br>Suture: Non-absorbable<br>braided polyester<br>Suture Sleeve: FEP Teflon<br>Shrink Tube, MIL-<br>1023053/11B or Polyester<br>Shrink Tube<br>Wire: 316 Stainless Steel | Single-Use<br>ETO Sterilization<br>Shipped Sterile | Anchor: 3.5mm x 10.5mm<br>Suture: USP Size #2 |
| PREDICATE<br>Linvatec<br>Bio-Anchor<br>510(k)<br>#K964805<br>#K963369 | Bio-Anchor | Soft tissue to bone<br>fixation for shoulder,<br>knee, foot, ankle,<br>elbow, wrist, hand, and<br>bladder neck suspension<br>procedures. | Poly (L-lactic)acid | Single-Use<br>ETO Sterilization<br>Shipped Sterile | 3.5mm x 10.5mm |
| PREDICATE<br>Linvatec<br>Pre-loaded Soft<br>Tissue Anchors<br>510(k)<br>#K953954 | Revo/Mini Revo | Soft tissue to bone<br>fixation. | Anchor: Titanium Alloy<br>Suture: Non-absorbable<br>braided polyester<br>Suture Sleeve: FEP Teflon<br>Shrink Tube, MIL-<br>1023053/11B or Polyester<br>Shrink Tube<br>Wire: 316 Stainless Steel | Single-Use<br>Gamma Sterilization<br>Shipped Sterile | Anchors: 2.5mm - 5.2mm<br>Suture: USP Sizes #0<br>to #2 |

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773

K983186 Re: Trade Name: Pre-loaded Bio-Anchor Absorbable Suture Anchor Requlatory Class: II Product Codes: MAI, HWC, and GAT September 10, 1998 Dated: Received: September 11, 1998

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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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 requlation (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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September 10, 1998

510(k) Number (if known): K983186

Device Name: Pre-loaded Bio-Anchor Absorbable Suture Anchor

Indications for Use:

The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

### Shoulder

- Bankart lesion repairs 1.
- 2. SLAP lesion repairs
- Acromio-clavicular separation repairs 3.
- Rotator cuff tear repairs বা বা বা বা বা করে আর করে আর করে আর করে আর করে আর করে আর করে আর করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার
- Capsular shift or capsulolabral reconstructions 5.
- Biceps tenodesis 6.
- Altoid repairs 7.

### Foot and Ankle

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

### Elbow, Wrist and Hand

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

#### Knee

- 1. Extracapsular 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

- Extracapsular reconstruction, Iliotibial band tenodesis 2.
- 3. Patellar realignment and tendon repairs

Pcodefe

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

Kg983182

**Prescription Use**
(Per 21 CFR 801.109)

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Indications for Use (con't):

### Bladder Neck Suspension

- l. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH Office of Device Evaluation (ODE) |
|-------------------------------------------------------|
|-------------------------------------------------------|

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983186 |

Prescription Use X OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

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(Optional Format 1-2-96)