← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K122334 # CHECKMATE SMALL BONE FUSION SYSTEM (K122334) _Arthrosurface, Inc. · HRS · Nov 28, 2012 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K122334 ## Device Facts - **Applicant:** Arthrosurface, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Nov 28, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities. ## Device Story CheckMate Small Bone Fusion System comprises 2-hole stainless steel bone plates and 2.0 mm/2.7 mm diameter bone screws. Plates feature pre-assembled suture loops for bone segment compression; screws include snap-off design for standalone fixation or plate use. Used by orthopedic surgeons in clinical settings for small bone stabilization. Device provides mechanical fixation to facilitate bone healing and fusion. Benefits include structural support and compression during surgical procedures. ## Clinical Evidence Bench testing only. Comparative static and dynamic four-point bending test results and dimensional/geometric analyses were used to demonstrate substantial equivalence. ## Technological Characteristics Implant grade stainless steel bone plates and screws. 2-hole plate configuration; 2.0 mm and 2.7 mm diameter screws (8-24 mm lengths). Features integrated suture loop for compression and screw snap-off mechanism. Mechanical fixation device. ## Regulatory 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. ## Predicate Devices - Arthrex, Inc. Distal Extremity Plate System ([K111253](/device/K111253.md)) - Smith & Nephew VLP Foot Plating, Screw System and Accessories ([K090675](/device/K090675.md)) - Synthes(USA) ([K071264](/device/K071264.md)) - Synthes (USA) 2.4/2.7 mm Locking Foot Module ([K063049](/device/K063049.md)) - Synthes (USA) Modular Mini Fragment LCP System ([K063049](/device/K063049.md)) - Wright Medical Technology, Inc. Charlotte™ Compression Plate ([K051908](/device/K051908.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ | Section 5 | 510(k) Summary | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604 | | Contact: | Dawn Wilson
VP, Quality & Regulatory | | Date of Preparation: | July 30, 2012 | | Trade Name: | CheckMate™ Small Bone Fusion System | | Common Name: | Bone Plates and Screws | | Device: | Plate, Fixation, Bone
Screw, Fixation, Bone | | Regulation Description: | Single/multiple component metallic bone fixation
appliances and accessories.
Smooth or threaded metallic bone fixation fastener | | Regulation Number: | 888.3030
888.3040 | | Device Class: | Class II | | Review Panel: | Orthopedic | | Product Code: | HRS
HWC | ### Intended Use The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities. {1}------------------------------------------------ ### Device Description The CheckMate™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture . loop intended to provide a traction force required to achieve compression between bone segments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel. ### Substantial Equivalency The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices: | • Arthrex, Inc.
Distal Extremity Plate System | K111253 | |------------------------------------------------------------------------------------------------|---------| | • Smith & Nephew
VLP Foot Plating, Screw System and Accessories | K090675 | | • Synthes(USA) | K071264 | | Synthes (USA) 2.4/2.7 mm Locking Foot Module
Synthes (USA) Modular Mini Fragment LCP System | K063049 | | • Wright Medical Technology, Inc.
Charlotte™ Compression Plate | K051908 | Comparative static and dynamic four-point bending test results, along with comparative dimensional and geometric analyses were used to support equivalence to predicate devices. The fundamental scientific technology of the proposed device has not changed relative to the predicate devices. {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 stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 28, 2012 Arthrosurface, Incorporated % Ms. Dawn Wilson Vice President, Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038 Re: K122334 Trade/Device Name: Checkmate Small Bone Fusion 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, HWC Dated: November 9, 2012 Received: November 13, 2012 Dear Ms. Wilson: 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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ #### Page 2 - Ms. Dawn Wilson 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. 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), please 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, # Ronald P. Jean for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Section 4 Indications for Use Statement 510(k) Number (if known): K122334 CheckMate™ Small Bone Fusion System Device Name: · #### Indications for Use: The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities. Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) · Concurrence of CDRH, Office of Device Evaluation (ODE) # Ronald P. Jean (Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122334 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K122334](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K122334) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com