NEXA BONE PLATE AND SCREW SYSTEM

{0}------------------------------------------------ # DEC 2 2 2005 #### 510 (k) Summary Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based: | Prepared: | December 6, 2005 | |------------------------|------------------------------------------------------------------------------------------------------------------------| | Applicant: | Nexa Orthopedics, Inc., (dba Futura Biomedical, LLC)<br>10675 Sorrento Valley Road, Suite 100<br>San Diego, CA 92121 | | Telephone: | 858-866-0660 | | Fax: | 858-866-0661 | | Contact: | Louise M. Focht | | Device Name: | Nexa bone plate and screw system | | Device Trade Name: | Nexa bone plate and screw system | | Device Classification: | Class II | | Reviewing Panel: | Orthopedic | | Regulation Number | 888.3030 | | Product Code: | 87 HRS | | Predicate Device: | K051884 Wright Medical Charlotte Small<br>MTP Fusion Plate<br>K033639 Acumed Lower Extremity<br>Congruent Plate System | | Registration Number: | 2030833 | | Owner Operator Number: | 9028319 | #### Device Description: The Nexa Orthopedics bone plate and screw system of plates and screws made of Stainless Steel (316L) and Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, ankle, hand, wrist, ulna and radius. The plates are provided in 4 sizes, right and left configuration. The screws are provided in 2 diameters 2.7 and 3.2 and lengths from 12-28 mm. The plates and screws are used for fracture fixation, fusion, and osteotomy of the bones of the foot. ### Indications for Use: The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomics. The system consists of plates and screws for treatment of the phalanges, and metatarsals. ] {1}------------------------------------------------ ## Comparison to Predicate Device: The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Charlotte Small MTP Fusion Plate Regulatory Class: II 87 HRS Product Code: Table 1 summarizes similarities and differences between the Nexa Orthopedics and the Wright Medical Charlotte Small MTP fusion plate system. | Item | Nexa Orthopedics System | Wright Medical Plate System | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | Nexa bone plate and screw system | Wright Medical Charlotte Small MTP Fusion<br>Plate | | Use | Single use | Single use | | Fixation | Screw | Screw | | Material | Stainless Steel | Stainless Steel | | Sizes | Plates 4 sizes, right and left<br>Screws dia 2.7mm, 3.2mm ,<br>length 12-28mm | Plates 2 sizes, right and left<br>Screws dia 2.7mm, 3.2mm ,<br>length 8-24mm | | Indications for use | The bone plate and screw system is intended<br>for use in providing fixation during fractures,<br>fusions and osteotomies. The system<br>consists of plates and screws for treatment of<br>the phalanges, and metatarsals. | The Charlotte Small MTP Fusion Plate is<br>intended to help increase the rate of bony<br>union, and to maintain the position of the toe<br>during fusion. Once the joint has fused, the<br>plate is secondary in the transmission of gait<br>forces.<br>• Fractures, osteotomies or<br>arthrodesis of the first metarsal-<br>phalangeal joint<br>• Deformity due to hallus valgus<br>• Deformity due to arthritis in the first<br>metatarsal-phalangeal joint<br>• Loss of motion-hallux rigidus<br>• Pain associated with osteoarthritis<br>or rheumatoid arthritis in the first<br>metatarsal-phalangeal joint<br>• Revision procedures where other<br>treatments or devices have failed;<br>and<br>• Chronic instability in the first<br>metatarsal-phalangeal joint | Similarities of the Nexa Orthopedies bone plate and serew system and Charlotte small MTP Fusion Plate system include: Both devices are: intended for single use only, intended for surgical implantation longer than 30 days; both devices are a system of plates and screws used for fixation of fracture, fusion, ostcotomics, of the metatarsal and phalangeal bones; both devices are made of ﺰ. ﺍ {2}------------------------------------------------ industry standard materials, no new materials are introduced in either product; Both madely bunnuard many sized; both devices have the same indications for use. Summary: The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 2 2005 Ms. Louise Focht Vice President of Research and Development Nexa Orthopedics, Inc. 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121 Re: K053408 Trade/Device Name: Nexa Bone Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: December 6, 2005 Received: December 7, 2005 Dear Ms. Focht: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) premained is substantially equivalent (for the indications felerenced above and nave user.imired by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or 10 commerce price to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The I ou may, mercrore, market the act include requirements for annual registration, listing of general controls proficious of wactice, 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 olabilition (600 a00 rols. Existing major regulations affecting your device can may be subject to sach additions, 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 nean I lease be devisou has i brinnation that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I catal suttates and regaranents, including, but not limited to: registration and listing (21 {4}------------------------------------------------ #### Page 2 - Ms. Louise Focht CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607); adomig (Dr CFR Part 820); and if applicable, the electronic forul in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastianon only of begin marketing your device as described in your Section 510(k) This iciter will anow you to ough maing of substantial equivalence of your device to a legally premarket notification: The PDF intemsgssification 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), please If you desire specific acriously 3 at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html. Sincerely yours, M. J. McFee Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510 (k) Number (If Known):__K053408 910 (K) Names: (Nexa bone plate and screw system ## Indications for Use: The bone plate and screw system is intended for use in providing fixation during I he bolle plate and screw system is intentive a consists of plates and screws for fractures, rasible phalanges, and metatarsals bones. Over-The-Counter Use Prescription Use _ >> AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K053408