TITAN RC TACK

K994269 · Innovasive Devices, Inc. · MAI · Jan 10, 2000 · Orthopedic

Device Facts

• Record ID: K994269
• Device Name: TITAN RC TACK
• Applicant: Innovasive Devices, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Jan 10, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titan RC Tack is intended for fixation of soft tissue to bone for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

Device Story

Titan RC Tack is a sterile, single-use bioabsorbable bone anchor for soft tissue reattachment in shoulder, knee, and ankle procedures. Device consists of three components: tip, sleeve, and pin. During surgery, pin is driven into sleeve, causing radial expansion of sleeve to secure fixation within host bone. Used by surgeons in clinical settings. Provides mechanical fixation of soft tissue to bone, facilitating healing. Bioabsorbable material eliminates need for secondary removal surgery.

Clinical Evidence

Bench testing only. In-vitro bone model testing evaluated ultimate holding strength at 3, 6, and 12 weeks to compare the bioabsorbable Titan RC Tack against the predicate device. Results demonstrated substantially equivalent performance.

Technological Characteristics

Bioabsorbable implant molded from L-PLA with color additive. Three-component design (tip, sleeve, pin). Fixation mechanism: radial expansion of sleeve. Sterile, single-use, 4.5mm size.

Indications for Use

Indicated for soft tissue to bone fixation in shoulder (rotator cuff tears, AC separation, biceps tenodesis, deltoid repair), knee (extra-capsular repairs, ligament reattachments, joint capsule closure, patellar tendon repairs, ITB tenodesis), and ankle (lateral/medial instability, Achilles tendon reconstruction/repair).

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

• Innovasive RC Tack (K992377)

Submission Summary (Full Text)

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JAN 1 0 2000

# 510(K) SUMMARY

## 1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: December 17, 1999

## 2. DEVICE:

Trade Name: Innovasive Titan RC Tack Common Name: Bone Anchor Class: II Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"

#### 3. PREDICATE DEVICE:

Innovasive RC Tack (K992377)

## 4. DEVICE DESCRIPTION:

The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.

## 5. INTENDED USE:

The Titan RC Tack is intended for fixation of soft tissue to bone for the following indications:

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#### SHOULDER

Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair

#### KNEE

Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis

## ANKLE

Lateral and medial instability Achilles tendon reconstruction and repair

## 6. COMPARISON OF CHARACTERISTICS:

The proposed Titan RC Tack, is a bioabsorbable version of the predicate RC Tack, and is therefore similar in design. The proposed device is molded from L-PLA with a color additive for implant visibility. The predicate device is molded from Delrin and HDPE. The proposed and predicate devices utilize the same method of bone fixation: radial expansion of the sleeve. Lastly, the indications being requested for the proposed Titan RC Tack are already cleared for the predicate RC Tack.

### 7. PERFORMANCE DATA:

The following performance data was proved in support of the substantial equivalence determination:

Bone Model Testing: the ultimate holding strength at 3, 6, and 12 weeks in-vitro.

The testing demonstrates substantially equivalent performance between the two devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 0 2000

Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices Incorporated 734 Forest Street Marlborough, Massachusetts 01752

Re: K994269 Titan RC Tack Product Code: MAI Regulatory Class: II Dated: December 17, 1999 Received: December 20, 1999

Dear Ms. Morahan:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 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.

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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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thos. W. Hays.

- Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## INDICATIONS FOR USE

The Titan RC Tack is intended for soft tissue to bone fixation for the following indications:

#### SHOULDER

Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair

#### KNEE

Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis

#### ANKLE

Lateral and medial instability Achilles tendon reconstruction and repair

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

Verrell Ingram or Jr

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