(28 days)
The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.
The Arthrex Compression Staple is a metal staple offered in five sizes.
The provided document is a 510(k) Summary for the Arthrex Compression Staple (K080111). This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies usually associated with AI/software devices.
The information provided focuses on:
- Manufacturer/Distributor/Sponsor: Arthrex, Inc.
- Trade Name: Arthrex Compression Staple
- Common Name: Fixation Staple
- Product Code - Classification Name: JDR - Single/multiple component metallic bone fixation appliances and accessories
- Predicate Device: Wright Medical Compression Staple, K043059
- Device Description and Intended Use: A metal staple in five sizes for various bone fixation procedures in the foot.
- Substantial Equivalence Summary: States that the Arthrex Compression Staple is substantially equivalent to the predicate Wright Medical Compression Staple, with basic features and intended uses being the same, and any differences being minor and not raising safety/effectiveness concerns.
In summary, there is no clinical study described in this 510(k) summary that evaluates medical device performance against specific acceptance criteria in the manner requested. The 510(k) process for this type of hardware device typically relies on demonstrating equivalence through comparison of design, materials, and mechanical properties, not through extensive clinical trials with human participant data and ground truth analysis as would be relevant for software-as-a-medical-device (SaMD) or AI-based systems.
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Image /page/0/Picture/1 description: The image shows the word "Arthrex" with a logo next to it, followed by the text "510(k): Arthrex Compression Staple< K080111". The text appears to be related to a medical device, possibly a compression staple. The "510(k)" likely refers to a premarket submission to the FDA for medical devices.
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
|---|---|
| 510(k) Contact | Sally Foust, RACRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1251Fax: 239/598.5508Email: sfoust@arthrex.com |
| Trade Name | Arthrex Compression Staple |
| Common Name | Fixation Staple |
| Product Code -Classification Name | JDR - Single/multiple component metallic bone fixationappliances and accessories |
| Predicate Devices | Wright Medical Compression Staple, K043059 |
| Device Description and IntendedUse | The Arthrex Compression Staple is a metal staple offered infive sizes.The Arthrex Compression Staple is intended to be usedfor fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, firstmetatarsophalangeal arthrodesis, Akin osteotomy,midfoot and hindfoot arthrodeses or osteotomies, fixationof osteotomies for hallux valgus treatment (Scarf andChevron), and arthrodesis of the metatarsocuneiformjoint to reposition, and stabilize metatarsus primus varus. |
| Substantial Equivalence Summary | The Arthrex Compression Staple is substantially equivalent tothe predicate Wright Medical Compression Staple in which thebasic features and intended uses are the same. Anydifferences between the Arthrex Compression Staple and thepredicate Wright Medical Compression Staple are consideredminor and do not raise questions concerning safety andeffectiveness. Based on the information submitted, Arthrex,Inc. has determined that the new Arthrex Compression Stapleis substantially equivalent to the currently marketed predicatedevice. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
FEB 13 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K080111
Trade/Device Name: Compression Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: January 15, 2008 Received: January 16, 2008
Dear Ms. Foust:
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.
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
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Page 2 -- Sally Foust, RAC
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. 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, 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
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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3 Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
Arthrex Compression Staple
The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.
Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
barbare michu
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K080111
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.