LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

{0}------------------------------------------------ K012409 ## OCT 1 8 2001 ## Summary of Safety and Effectiveness #### Specification Holder: Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218-2480 Establishment Registration: 1032347 Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of Biomet, Inc. | Contact Person: | Sheryl Malmberg<br>Walter Lorenz Surgical, Inc.<br>Jacksonville, FL 32218<br>Phone: (904) 741-4400 ext. 255<br>Fax: (904) 741-4500 | |-----------------|------------------------------------------------------------------------------------------------------------------------------------| |-----------------|------------------------------------------------------------------------------------------------------------------------------------| Lorenz LactoSorb® Laryngotracheal Reconstruction Implants Proprietary Name: Ear Nose & Throat Synthetic Polymer Material Common Name: Classification Name: 21 CFR 874.3620 Legally Marketed Devices to which substantial Equivalence is Claimed: Eliachar Laryngeal foam Stent (K000154), Lorenz Stent (K896667), and Montgomery Laryngeal Stent (K842287). Device Description: The Lorenz Lactosorb® Laryngotracheal Reconstruction (LTR) Implants consist of mesh sheets for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia, and graft plates for lumen augmentation in the temporary treatment and repair of glottic stenosis. The mesh sheets are 0.75mm thick and 50mm wide by 50mm long. The mesh sheets are offered with two different hole configurations to facilitate attachment to the tracheal cartilage using suture and/or screws. The graft plate is a one-piece device consisting of a rectangular base with an elliptical top. The top is available in widths of 3mm, 4mm, 5mm, and 6mm to allow for various amounts of augmentation of the lumen. The base is 0.5mm thick and 10mm wide by 15mm long. The base has holes around the outer edges to allow for fixation to the tracheal cartilage using suture and/or screws. The Lactosorb® Screws and Lactosorb® Direct Drive Screws have a 1.5 diameter with a range of lengths available from 3 to 8mm. Intended Use: The Lorenz Lactosorb® Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia and lumen augmentation in the temporary treatment and repair of glottic stenosis. {1}------------------------------------------------ #### Summary of Technologies: | Comparison<br>Information | Lorenz Lactosorb®<br>Laryngotracheal<br>Reconstruction<br>Implants | Eliachar Laryngeal<br>Foam Stent | Lorenz Stent | Montgomery<br>Lryngeal Stent | |---------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Walter Lorenz<br>Surgical, Inc. | Hood Laboratories | Walter Lorenz<br>Surgical, Inc. | Boston Medical<br>Products, Inc. | | 510(k) | New | K000154 | K896667 | K842287 | | Indications for Use | Reconstruction for<br>stenosis,<br>tracheomalacia, and<br>laryngeal fracture. | Reconstruction for<br>stenosis and<br>laryngeal fracture. | Glottic and<br>subglottic stenosis<br>aud upper tracheal<br>stenois with or<br>without laryngeal<br>stenosis | For the prevention<br>and treatment of<br>laryngeal stenosis<br>when the glottic<br>stenosis involves<br>the midglottis,<br>posterior glottis,<br>supraglottis, and<br>subglottis,<br>singularly or in<br>combination. | | Design | Prefabricated | Prefabricated | Prefabricated | Prefabricated | | Material | Lactosorb® | Silicone Foam | PTFE | Silicone | | Sizes | 50 x 50mm mesh,<br>50 x 50mm sheet<br>15 x 10mm plate<br>with 4 available top<br>width sizes (3,4,5,<br>and 6mm) | 2 sizes: 25mm,<br>40mm, 15mm and<br>25mm, 52mm,<br>17mm | 16 sizes, ranging<br>from 6 mm to<br>18mm | Child, Small Adult,<br>Medium Adult, and<br>Large Adult | | Method of Placement | Screws and/or<br>Sutures | Adherence to<br>laryngeal contours<br>with strap for<br>additional control<br>and anchoring | Sutures | Sutures with<br>silicone buttons | | Method of<br>Deployment | Not applicable | Not applicable | Not applicable | Not applicable | Non - Clinical Testing: Animal studies have been undertaken demonstrating the acceptability of Lactosorb® implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants represent an advancement in the management of tracheomalacia and other conditions requiring temporary airway stenting, including graft procedures. Studies have been undertaken demonstrating the acceptability of Lactosorb® Clinical Testing: implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants were well tolerated by tissue and provided adequate support for healing of bone and cartilage, along with the potential advantage of a lack of interference with growth. Lactosorb is a trademark of Biomet, Inc. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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, with a human profile visible in the negative space between the wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 8 2001 Walter Lorenz Surgical, Inc. c/o Ms. Sheryl Malmerg Regulatory Manager 1520 Tradeport Drive Jacksonville, FL 32218-2480 Re: K012409 Trade/Device Name: Lorenz Resorbable Laryngotracheal Reconstruction Implants Regulation Number: 21 CFR 874.3620 Regulation Name: Ear Nose and Throat Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: July 19, 2001 Received: July 30, 2001 Dear Ms. Malmerg: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally presidents in a classification for your device and thus, permits 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Lorenz Resorbable Laryngotracheal Reconstruction Implants ## Indications For Use: The Lorenz Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the The Lorenz Resorbable Laryligotracheal Recomed Seconders, Maryneofracheomalacia, and lumen temporaly treatment and repair of raily agently of glottic stenosis. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) | <div> <span style="text-decoration: overline;">✓</span> </div> | OR | Over-The-Counter-Use (Optional Format 1-2-96) | |---------------------------------------|----------------------------------------------------------------|----|-----------------------------------------------| |---------------------------------------|----------------------------------------------------------------|----|-----------------------------------------------| | (Division Sign-Off) | <div> <img alt="Signature" src="signature.png" width="100"/> </div> | |--------------------------------|---------------------------------------------------------------------| | Division of Ophthalmic Devices | | | 510(k) Number | 2012409 | 001