OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS

{0}------------------------------------------------ K103309 p 1 of 3 Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 978 749 1000 978 749 1599 Fax www.smith-nephew.com # >< We are smith&nephew FEB - 3 2011 ## SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based. #### OSTEORAPTOR Curved 2.3 Suture Anchor Date Prepared: November 8, 2010 #### A. Submitter's Name: Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 #### B. Company Contact Kathleen Solomon Regulatory Affairs Specialist II Phone: (978) 749-1605 Fax: (978) 749-1443 #### C. Device Name | Trade Name: | OSTEORAPTOR Curved 2.3 Suture Anchor | |----------------------|---------------------------------------------------------------------------------| | Common Name: | Fastener, fixation, biodegradable, soft tissue | | Classification Name: | Single/multiple component metallic bone fixation<br>appliances and accessories. | | Product Code: | MAI | | Regulation Number: | 21 CFR §888.3030 | #### D. Predicate Device The Smith & Nephew OSTEORAPTOR Curved 2.3 Suture Anchors are substantially equivalent in Indication for Use and Fundamental Scientific Technology to the OSTEORAPTOR 2.3 Suture Anchor, K082215. {1}------------------------------------------------ #### E. Description of Device The Smith & Nephew OSTERAPTOR Curved 2.3 Suture Anchor is bioabsorbable 2.3 mm suture anchor manufactured from PLLA/HA and comes preloaded with nonabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter. ## F. Intended Use The OSTERAPTOR Curved 2.3 suture anchors are intended for the fixation of soft tissue to bone in the Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee as follows: #### Hip Hip capsule repair - Acetabular labrum reattachment ## Shoulder Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis #### Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair #### Knee - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Patellar realignment and tendon repairs – Vastus medialis obliquous advancement Iliotibial band tenodesis #### Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy {2}------------------------------------------------ ## G. Comparison of Technological Characteristics The Smith & Nephew OSTERAPTOR Curved 2.3 Suture Anchors are substantially equivalent in indications for use, technological characteristics, and are as safe and as effective as their currently marketed predicate device, the Smith & Nephew OSTERAPTOR 2.3 Suture Anchor (K082215). ## H. Summary Performance Data The performance testing demonstrates that the insertion, pull out and suture slide properties of the OSTEORAPTOR Curved 2.3 anchors are substantially equivalent to the Smith & Nephew OSTEORAPTOR 2.3 anchors. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an emblem that resembles an abstract depiction of an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Smith & Nephew, Inc. Endoscopy Division % Ms. Kathleen Solomon Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810 FEB - 3 2011 Re: K103309 Trade/Device Name: OSTEORAPTOR Curved Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: MAI, JDR Dated: November 8, 2010 Received: November 10, 2010 Dear Ms. Solomon: 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical {4}------------------------------------------------ ## Page 2 - Ms. Kathleen Solomon device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), vlease go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, AS B. R h for. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Indications for Use K 103309 Elbow, Wrist, and Hand reconstructions Knee Biceps tendon reattachment Lateral epicondylitis repair - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Extra-capsular repairs: Ulnar or radial collateral ligament 510(k) Number (if known): Device Name: OSTEORAPTOR Curved Suture Anchors Indications For Use: The Smith & Nephew OSTERAPTOR Curved Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: ## Hip Hip capsule repair - Acetabular labrum reattachment #### Shoulder Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis ## Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) Prescription Use X (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Offjes of Device Evaluation (ODE) (Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices 22 of 126 Smith & Nephew Endoscopy OSTEORAPTOR Curved 2.3 Suture Anchor 510(k) Number