MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C

K071437 · KARL STORZ Endoscopy-America, Inc. · HWC · Sep 12, 2007 · Orthopedic

Device Facts

• Record ID: K071437
• Device Name: MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

Device Story

KSEA MegaFix®-C is a single-use, bioabsorbable composite interference screw; used for primary anchorage of tendon grafts during cruciate ligament reconstruction. Device implanted by surgeons in clinical/OR settings. Screw provides mechanical fixation of graft to bone; material composition allows for gradual absorption over time. Benefits include secure graft stabilization during healing process without need for permanent metallic hardware.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Threaded bone fixation screw; materials include poly-(L-co-D,L-lactide) 70/30 with β-TCP or poly-(L-co-D,L-lactide) 70/30; dimensions: 7-9mm diameter, 19-28mm length; single-use; sterile; bioabsorbable.

Indications for Use

Indicated for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction by qualified surgeons.

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

• KSEA MegaFix® (K013107)
• Sciences for Biomaterials Ligafix® (K061262, K050407)
• Conmed Linvatec Biomaterials Matryx™ (K063588, K052080)
• DePuy Mitek Milagro (K060830)

Submission Summary (Full Text)

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K071437 pg. 142

Image /page/0/Picture/1 description: The image shows the logo for STORZ, a company specializing in endoscopy. The logo features the word "STORZ" in bold, sans-serif font, with the "O" replaced by a target-like symbol. Below the main logo, the words "KARL STORZ ENDOSCOPY" are printed in a smaller, sans-serif font.

## 510(k) SUMMARY

| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe<br>Culver City, CA 90230-7600<br>Phone: [phone]<br>Fax: [phone] | SEP 12 2007 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Crystal Dizol<br>Regulatory Affairs Associate<br>Email: [e-mail] | |
| Date of Submission: | May 17, 2007 | |
| Device Trade Name: | KSEA MegaFix®-C Bioabsorbable Composite Interference Screw | |
| Common Name: | Bioabsorbable Composite Interference Screw | |
| Classification Name: | Screw, Fixation, Bone | |
| Regulation Number: | 21 CFR 888.3040 | |
| Product Code: | HWC | |
| Predicate Device(s): | KSEA MegaFix® (K013107)<br>Sciences for Biomaterials Ligafix® (K061262, K050407)<br>Conmed Linvatec Biomaterials Matryx™ (K063588, K052080)<br>DePuy Mitek Milagro (K060830) | |
| Device Description: | The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is a one-<br>time use biodegradable implant, provided to the end user in a sterile condition,<br>and intended for interference fixation of grafts in human cruciate ligament<br>reconstruction. The device is a bioabsorbable composite interference screw<br>which utilizes lactide polymer composite technology to perform the intended use. | |
| Indications for Use: | The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is<br>indicated for use for tibial and femoral fixation (primary anchorage) of tendon<br>grafts in human cruciate ligament reconstruction. | |
| Technological<br>Characteristics: | The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw and its<br>predicate devices are threaded bone fixation screws that provide primary<br>anchorage of tendon transplants until absorbed | |

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| Material | Dimensions (mm) | Design | Use | Intended Use |
|----------------------------------------|------------------------------------|-------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| poly-(L-co-D,L-lactide)<br>70/30/β-TCP | Diameters: 7-9<br>Lengths: 19-28 | Threaded<br>Screw | Single Use | For use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction. |
| poly-(L-co-D,L-lactide)<br>70/30 | Diameters: 7-9<br>Lengths: 19-28 | Threaded<br>Screw | Single Use | For use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction. |
| polylactic acid/β-TCP | Unavailable | Threaded<br>Screw | Single Use | For use in anterior cruciate ligament reconstruction to provide interference fixation of grafts. |
| poly-(L-co-D-lactide)/β-TCP | Diameters: 7.3-9<br>Lengths: 20-30 | Threaded<br>Screw | Single Use | For use in interference fixation of bone – patellar tendon – bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. |
| poly-(lactide-co- | Diameters: 7-12 | Threaded | | For the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Also for medial and |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy-America, Inc. c/o Ms. Crystal Dizol Regulatory Affairs Associate 600 Corporate Pointe Culver City, CA. 90230-7600

SEP 1 2 2007

Re: K071437

> Trade/Device Name: KSEA MegaFix®-C Bioabsorbable Composite Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 17, 2007 Received: June 19, 2007

Dear Ms. Dizol:

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.

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Page 2 -- Ms. Crystal Dizol

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 marketed predicate device results in a classification for your device and thus, permitts your evice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation only) program "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For and tions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain ther groered information on your responsibilities under the Act from the Division of Small Monufacturers, International and Consumer Assistance at toll-free number [phone] or 240-276e3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Harbare Brehm

Tor

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K071437

KSEA MegaFix®-C Bioabsorbable Composite Interference Screw Device Name:

Indications for Use: The KSEA MegaFix®-C Elioabsorbable Composite Interference Screw is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

× Prescription Use: (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: (21 CFR 801 Subpart C)

x/0

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Calbara Bueno som
Division Sign-Off

Division of General, Restorative, and Neurological Devices

**510(k) Number** k071437

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