IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR

K011943 · Kensey Nash Corp. · LZN · Sep 19, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011943
• Device Name: IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
• Applicant: Kensey Nash Corp.
• Product Code: LZN · General, Plastic Surgery
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable cement flow restrictor in the intramedullary canal. This device is not intended for use in the spine.

Device Story

ImproVise™ Absorbable Cement Flow Restrictor is a sterile, absorbable foam plug used in orthopedic surgery; specifically, large joint replacement procedures. Device is inserted into the intramedullary canal of long bones to act as a barrier, preventing bone cement from migrating deeper into the canal during cementation. The surgeon selects a plug based on canal size, mounts it onto an insertion tool, and places it at the desired depth. The foam material is deformable, allowing it to conform to the canal shape and create a friction fit. The device is manufactured from polylactic acid foam with >90% void space. It is intended for use in hospital operating rooms by orthopedic surgeons. By sealing the canal, the device ensures proper cement containment, which can improve the stability of the implant and benefit the patient by optimizing the surgical outcome.

Clinical Evidence

Bench testing only. Performance was evaluated by measuring push-out force to ensure the device maintains its position in the intramedullary canal. No clinical data was required or provided.

Technological Characteristics

Material: Polylactic acid. Architecture: Foam with >90% void space. Form factor: Cylindrical and tapered shapes in various sizes (9.5-17.5 mm). Principle: Mechanical friction fit. Sterilization: Gamma radiation. No software or electronic components.

Indications for Use

Indicated for patients undergoing orthopedic procedures in long bones requiring bone cement, specifically for use as an absorbable cement flow restrictor in the intramedullary canal. Not for use in the spine.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Resorbaplug™ Bone Plug (K920118)

Submission Summary (Full Text)

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## 510(k) Summary

Class II

LZN

Kensey Nash Corporation

55 East Uwchlan Avenue

Exton, PA 19341 USA

Koi194/3

Company: Address:

Phone: Fax:

Proprietary Name: Common Name: Classification Name and Reference: Proposed Regulatory Class: Device Product Code:

610-524-0188 610-524-0265 ImproVise™ Absorbable Cement Flow Restrictor Bone Plug Cement Obturator (reference unknown)

### For information, contact:

Robin M. Fatzinger Requlatory Affairs Manager Telephone: [phone] Fax: [phone] Email: [e-mail]

June 20, 2001

# Date Summary Prepared: Device Description:

The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, The improvise - Absorbable Ochton I tramedullary canal with an easy-to-place absorbable and chective method of playing the reamer used to form the channel, the appropriate size foam plug. "Dased on the Size of the roamid aboth the canal to the desired depth, using the Cement resultion is scieolor and is them garded onto the tip of the tool. The ImproVise™ Improvise - Inscrition tool. I lago will be progular shape of the canal, effectively toam plugs are deformable and bank tans on the it restrictors are available in sizes small, sealing the canar at the motion in point. The sements of 9.5-11 mm, 11-13 mm, 13-15 mm, medium, large and extraight cylindrical and tapered versions. The restrictor can be aria 13-17.5 min), both in struight bylindhour and or a careery or press-fit into the bone. The ImproVise™ easily Carved with a scalper at the time of ourger, or proprietary polylactic acid foam.
Absorbable Cement Flow Restrictor is manufactured from a propriet Absorbance Ocmont How Receivere which is greater than 90% void space.

#### Intended Use:

The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable The improvise - Absorbable our for use in the intramedullary canal. This device is not intended for use in the spine.

### Substantial Equivalence:

Stantial Equivalenoo.
The intended use, material and design of the ImproVise™ Absorbank Flow The liftended use, material and thus substantially equivalent to the Resorbapliug™ Bone Resultion are heany lightlear and this Gabor Danek division of Medtronic, Inc.) (K920118). See Table 1 below for a comparison of the two devices.

Revised December 12, 2001.

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| | ImproVise™<br>Absorbable Cement Flow Restrictor<br>(Kensey Nash Corporation) | Resorbaplug™ Bone Plug<br>(Danek Group) |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Status | New Device | Predicate |
| Intended Use | Bone cement flow restrictor for intra-<br>medullary canal | Bone cement flow restrictor for<br>intramedullary canal |
| Target Population | Patients undergoing orthopedic<br>procedures (large joint replacement<br>requiring use of bone cement) | Patients undergoing orthopedic<br>procedures (large joint<br>replacement requiring use of<br>bone cement) |
| Anatomical Sites of Use | Orthopedic procedures in the long bones | Orthopedic procedures in the long<br>bones |
| Material | Polylactic acid | Polylactic acid |
| Architecture | Foam | Foam |
| Manufacturing Process | Proprietary foaming process | Proprietary foaming process |
| Shape | Cone, cylinder | Cone, cylinder |
| Size | Small (9.5-11 mm), medium (11-13 mm),<br>large (13-15 mm), and extra-large (15-<br>17.5 mm) | 14, 20 and 26 mm in diameter |
| Sterilization | Gamma radiation | Gamma radiation |
| Where Used | Hospital operating room | Hospital operating room |
| Principle of Operation | Foam plug conforms to shape of<br>intramedullary canal and is friction fit to<br>proper depth; plug prevents bone<br>cement from migrating deeper into the<br>canal. | Foam plug conforms to shape of<br>intramedullary canal and is friction<br>fit to proper depth; plug prevents<br>bone cement from migrating<br>deeper into the canal. |
| Performance<br>Interference fit that<br>provides 100N push-out<br>force | 1.9-2.9 mm | 2.5 mm |
| Safety Characteristics | Biocompatibility of material,<br>demonstrated push-out forces | Biocompatibility of material,<br>demonstrated push-out forces |

# Table 1: Substantial Equivalence of ImproVise™ and Resorbaplug™

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

SEP 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Julie N. Broderick Vice President of Clinical and Regulatory Affairs Kensey Nash Corporation 55 East Uwchlan Avenue Exton, Pennsylvania 19341

Re: K011943

Trade/Device Name: Impro Vise™ Absorbable Cement Flow Restrictor Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: LZN Dated: June 20, 2001 Received: June 21, 2001

Dear Ms. Broderick:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becaon o r (x) presses is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to charactment date of the Medical Device Amendments, or to Commerce proof to May 20, 1978, are cassified in accordance with the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general obliness provided in a sactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is exactined (tional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of action and I Draination that your device complies with other requirements of the Act that I Dr has intact a avoid regulations administered by other Federal agencies. You must of any I catal suttated and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also qualis) 25 total provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Ms. Julie N. Broderick

This letter will allow you to begin marketing your device as described in your Section 510(k) I ma lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premaince noticate 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sus-Walk, us

\$\infty\$

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Celia M. Witten, Ph.D., M.D.

Enclosure

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# INDICATIONS FOR USE

510(K) NUMBER (IF KNOWN):

K011943

DEVICE NAME: ImproVise™ Absorbable Cement Flow Restrictor

or

## INDICATIONS FOR USE:

The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable The Inford ISC Ausorbable Coment In the intramedullary canal. This device is not intended for use in the spine.

Please do not write below this line – Use another page if necded

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use I (per 21 CFR 801.109) Over-the-counter Use _________

SR

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011943

003