RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454

K992458 · Innovasive Devices, Inc. · MBI · Oct 14, 1999 · Orthopedic

Device Facts

• Record ID: K992458
• Device Name: RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
• Applicant: Innovasive Devices, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed RC Multi-Suture Anchor is intended for soft tissue reattachment to host 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

RC Multi-Suture Anchor is a sterile, single-use, 4.5mm bone anchor; consists of three-piece polymer implant assembled on delivery shaft. Used for soft tissue-to-bone fixation in shoulder, knee, and ankle. Operated manually by surgeon using delivery handle. Device provides mechanical fixation of soft tissue to bone. Benefit includes secure reattachment of ligaments and tendons to host bone. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only. Bone model testing compared ultimate holding strength of RC Multi-Suture Anchor to predicate ROC EZ Suture Bone Fastener. Results showed subject device holding strength was greater than predicate.

Technological Characteristics

Three-piece polymer implant; 4.5mm size; manual delivery system; sterile, single-use. Mechanical fixation principle.

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 reattachment, joint capsule closure, patellar ligament/tendon avulsion, ITB tenodesis), and ankle (lateral/medial instability, Achilles tendon reconstruction/repair). Prescription use only.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Innovasive ROC EZ Suture Bone Fastener (K970089, K971922)

Submission Summary (Full Text)

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# OCT 1 4 1999

#### 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: July 2, 1999

### 2. DEVICE:

Trade Name: RC Multi-Suture Anchor

Common Name: Bone Anchor

Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"

# 3. PREDICATE DEVICE:

The Innovasive ROC EZ Suture Bone Fastener (K970089, K971922).

#### 4. DEVICE DESCRIPTION:

The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.

#### 5. INTENDED USE:

The proposed RC Multi-Suture Anchor is intended for soft tissue reattachment to host 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 RC Multi-Suture Anchor utilizes the same materials as the predicate ROC EZ Suture Bone Fastener and the same method of bone fixation. The indications being requested for the proposed RC Multi-Suture Anchor are cleared for the predicate ROC EZ Suture Bone Fastener.

### 7. PERFORMANCE DATA:

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

Bone Model Testing: the ultimate holding strength of the proposed RC Multi-Suture Anchor was compared to the currently marketed ROC EZ Suture Bone Fastener. The holding strength of the proposed RC Multi-Suture Anchor was greater than that of the predicate device, demonstrating substantially equivalent performance between the devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Ms. Kathleen Morahan Requlatory Affairs Specialist Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts

Re: K992458 RC Multi-Suture Bone Anchor Regulatory Class: II Product Codes: MBI and GAT Dated: July 19, 1999
Received: July 23, 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸਿ 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 requlations.

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## Page 2 - Ms. Kathleen Morahan

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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# INDICATIONS FOR USE

The RC Multi-Suture Anchor 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

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Division ivision of General Restorative De 510(k) Numb

Prescription Use J (Per 21 CFR 801.109)