SYNPLUG

K010840 · Isotis NV · LZN · Apr 20, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K010840
• Device Name: SYNPLUG
• Applicant: Isotis NV
• Product Code: LZN · General, Plastic Surgery
• Decision Date: Apr 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SynPlug is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

Device Story

SynPlug™ is a cement restrictor used during cemented hip and shoulder arthroplasty. It functions as a physical barrier to prevent cement leakage and migration within the intramedullary canal. The device features a cylindrical shape with five flanges and increased rigidity compared to its predecessor. It is available in 13 sizes to fit canal diameters ranging from 9 to 21 mm. The device is used by surgeons in an operating room setting. An accompanying instrumentation set, including measuring probes and insertion rods, assists the surgeon in selecting the appropriate size and ensuring correct placement. By effectively occluding the canal, the device helps maintain cement pressure, potentially improving the quality of the arthroplasty fixation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Cylindrical cement restrictor; 13 sizes for 9-21 mm intramedullary canal diameters; features five flanges; increased rigidity compared to predicate; non-active, mechanical device; includes stainless steel or similar instrumentation (measuring probes and insertion rods).

Indications for Use

Indicated for intramedullary occlusion during cemented hip and shoulder arthroplasty in patients requiring such procedures.

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

• Shuttle Stop® (K000587)

Submission Summary (Full Text)

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KOI0846

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# 510(k) Summary Special 510(k): Device Modification SynPlug™

#### 1. SPONSOR

IsoTis NV Prof. Bronkhorstlaan 10-D 3723 MB Bilthoven The Netherlands

Contact Person: F.J.C. van Strien, Ph.D. [phone] Telephone:

Date Prepared: March 20, 2001

## 2. DEVICE NAME

Proprietary Name: SynPlug™ Common/Usual Name: Cement restrictor Classification Name: Cement obturator

### 3. PREDICATE DEVICE

Shuttle Stop® (K000587)

## 4. DEVICE DESCRIPTION

The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following:

- Adoption of a cylindrical shape for the proposed SynPlug ●
- Elimination of sidewall slots and addition of five flanges .

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K010846 p²/2

- Increase in the rigidity of the proposed device .
- Expansion of the number of available sizes for the proposed device to 13, . designed to fit intramedullary canal diameters of 9 to 21 mm

This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

#### INTENDED USE ട്.

The SynPlug is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

#### 6. BASIS OF DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The proposed SynPlug is a modification of the Shuttle Stop and is therefore substantially equivalent to the Shuttle Stop cement restrictor. The intended use and technological characteristics of the proposed and parent devices are identical. Differences are limited to the design modifications listed in Section 4. These design modifications were validated according to IsoTis' Design Control Procedures, in compliance with the design control procedure requirements of the Quality Systems Regulations as specified in 21 CFR 820.30. The differences between the proposed and parent devices are minor and do not raise new issues of safety or effectiveness.

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APR 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IsoTis NV c/o Cynthia J. M. Nolte, Ph.D. Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K010840

Trade Name: SynPlug™ Regulation Number: Unclassified Product Code: LZN Dated: March 20, 2001 Received: March 21, 2001

Dear Dr. Nolte:

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 Costical Fee (110). I 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.

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# Page 2 - Cynthia J. M. Nolte, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will and in Journey of substantial equivalence of your device to a premaired predicated. - The vice 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Miriam C. Provost

tol 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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510(k) Number (if known):

KO10840

SynPlug™ Device Name:

Indications for Use:

SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam l. Provost

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

510(k) Number k010846

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

IsoTis Special 510(k) SynPlug™

March 20, 2001